Trial Outcomes & Findings for Hypofractionated Radiotherapy for the Treatment of Cervical or Endometrial Cancer (NCT NCT05139368)

Last Updated: 2026-09-04

Results Overview

Change in toxicity will be measured by the change in bowel domain score as assessed on the Expanded Prostate Cancer Index Composite (EPIC) instrument. EPIC is a 26-item, self-assessed questionnaire rated on a 5-point Likert scale. 14 items in this assessment create the Bowel Summary score. Bowel Summary scores are transformed linearly to a 0-100 scale, with higher scores indicating better Health-related Quality of Life (HRQOL) and lower scores indicating worse HRQOL. This outcome measure will report mean change in the Bowel Summary Score. A positive change indicates the scores increased (improved HRQOL) and a negative Change indicates the scores decreased (worse HRQOL). This outcome measure will report mean EPIC Bowel Summary scores at the week 3 timepoint.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

22 participants

Primary outcome timeframe

from baseline to the week 3 timepoint, up to 6 weeks from the baseline visit

Results posted on

2026-09-04

Participant Flow

Results from this study are preliminary, and meaningful conclusions should not be drawn from the small sample size.

Participant milestones

Participant milestones
Measure	Treatment (Hypo-fractionated Radiotherapy) Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Overall Study STARTED	22
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Hypo-fractionated Radiotherapy) Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Overall Study Adverse Event	1

Baseline Characteristics

Hypofractionated Radiotherapy for the Treatment of Cervical or Endometrial Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Hypo-fractionated Radiotherapy) n=22 Participants Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Inte Somewhat	1 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Inte Quite a bit	0 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Inte Very much	0 Participants n=23 Participants
Functional Assessment of Cancer Therapy-Cervix (FACT-Cx).	132.37 score on a scale STANDARD_DEVIATION 19.68 • n=23 Participants
FACIT Measure of Financial Toxicity (FACIT-COST) Score	28.33 score on a scale STANDARD_DEVIATION 10.45 • n=23 Participants
Prior Cancer Diagnosis Yes	5 Participants n=23 Participants
Age, Categorical <=18 years	0 Participants n=23 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=23 Participants
Age, Categorical >=65 years	10 Participants n=23 Participants
Sex: Female, Male Female	22 Participants n=23 Participants
Sex: Female, Male Male	0 Participants n=23 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=23 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=23 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=23 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=23 Participants
Race (NIH/OMB) Asian	1 Participants n=23 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=23 Participants
Race (NIH/OMB) Black or African American	0 Participants n=23 Participants
Race (NIH/OMB) White	20 Participants n=23 Participants
Race (NIH/OMB) More than one race	0 Participants n=23 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=23 Participants
Region of Enrollment United States	22 participants n=23 Participants
FIGO Grade Grade X (GX)	0 Participants n=23 Participants
FIGO Grade Grade 1 (G1)	7 Participants n=23 Participants
FIGO Grade Grade 2 (G2)	7 Participants n=23 Participants
FIGO Grade Grade 3 (G3)	8 Participants n=23 Participants
Prior Cancer Diagnosis No	17 Participants n=23 Participants
BMI	34.01 kg/m^2 STANDARD_DEVIATION 9.86 • n=23 Participants
EPIC Bowel Summary Score	86.73 score on a scale STANDARD_DEVIATION 12.82 • n=23 Participants
EPIC Urine Summary Score	92.08 score on a scale STANDARD_DEVIATION 9.86 • n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Never	10 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Rarely	6 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Occasionally	5 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Frequently	1 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Almost Constantly	0 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Never	10 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Rarely	7 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Occasionally	5 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Frequently	0 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Almost constantly	0 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen None	11 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Mild	10 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Moderate	1 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Severe	0 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Very severe	0 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Not at all	18 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen A little bit	4 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Somewhat	0 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Quite a bit	0 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Very much	0 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Never	17 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Rarely	4 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Occasionally	1 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Frequently	0 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Almost constantly	0 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Inte Not at all	18 Participants n=23 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Inte A little bit	3 Participants n=23 Participants

PRIMARY outcome

Timeframe: from baseline to the week 3 timepoint, up to 6 weeks from the baseline visit

Population: One participant was taken off the study before the Week 3 study visits. One participant missed this survey at Week 3.

Outcome measures

Outcome measures
Measure	Treatment (Hypo-fractionated Radiotherapy) n=20 Participants Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Change in Toxicity - Bowel Summary Score	-23.07 score on a scale Interval -31.54 to -14.6

PRIMARY outcome

Timeframe: Baseline to week 3 (up to 6 weeks from the baseline visit)

To assess the feasibility of administering a clinical trial to evaluate hypofractionated radiotherapy. This outcome measure will report the number of evaluable patients and the number of patients who started study treatment but were not deemed evaluable. To be considered evaluable, an eligible patient must have completed 3 weeks of treatment and completed EPIC bowel domain questionnaire at baseline and 3 weeks.

Outcome measures

Outcome measures
Measure	Treatment (Hypo-fractionated Radiotherapy) n=22 Participants Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Trial Feasibility - Number of Evaluable Patients Evaluable	20 Participants
Trial Feasibility - Number of Evaluable Patients Not Evaluable	2 Participants

SECONDARY outcome

Timeframe: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

Population: One participant was taken off the study before the Week 3 and Year 1 study visits. One participant missed this survey at Week 3. Two participants were taken off the study before the Year 1 visit.

Change in urinary toxicity will be measured by the change in urinary summary score as assessed on the Expanded Prostate Cancer Index Composite (EPIC) instrument. EPIC is a 26-item, self-assessed questionnaire rated on a 5-point Likert scale. 10 items in this assessment create the Urine Summary score. Urine Summary scores are transformed linearly to a 0-100 scale, with higher scores indicating better Health-related Quality of Life (HRQOL) and lower scores indicating worse HRQOL. This outcome measure will report mean change in the Urine Summary Score. A positive change indicates the scores increased (improved HRQOL) and a negative Change indicates the scores decreased (worse HRQOL). This outcome measure will report mean EPIC Urine Summary scores at the week 3 and 1 year timepoint.

Outcome measures

Outcome measures
Measure	Treatment (Hypo-fractionated Radiotherapy) n=20 Participants Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Change in Urinary Domain of the Expanded Prostate Cancer Index Composite (EPIC) Instrument Week 3	-8.41 score on a scale Interval -12.4 to -4.42
Change in Urinary Domain of the Expanded Prostate Cancer Index Composite (EPIC) Instrument Year 1	-4.86 score on a scale Interval -8.54 to -1.17

SECONDARY outcome

Timeframe: Baseline to 1 year (up to 14 months from the baseline visit)

Population: One participant had an incomplete survey at the Year 2 visit. Three participants were taken off the study before the Year 1 visit.

Outcome measures

Outcome measures
Measure	Treatment (Hypo-fractionated Radiotherapy) n=18 Participants Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Change in Bowel Domain of the Expanded Prostate Cancer Index Composite (EPIC) Instrument	-2.88 score on a scale Interval -7.91 to 2.16

SECONDARY outcome

Timeframe: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing how OFTEN participants experienced Loose or Watery Stools (Diarrhea) in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).

Outcome measures

Outcome measures
Measure	Treatment (Hypo-fractionated Radiotherapy) n=20 Participants Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Week 3 · Never	1 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Week 3 · Rarely	2 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Week 3 · Occasionally	2 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Week 3 · Frequently	11 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Week 3 · Almost constantly	4 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Year 1 · Never	6 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Year 1 · Rarely	7 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Year 1 · Occasionally	2 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Year 1 · Frequently	4 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Year 1 · Almost constantly	0 Participants

SECONDARY outcome

Timeframe: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing how OFTEN participants experienced Pain in the Abdomen (Belly Area) in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).

Outcome measures

Outcome measures
Measure	Treatment (Hypo-fractionated Radiotherapy) n=20 Participants Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Week 3 · Never	5 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Week 3 · Rarely	6 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Week 3 · Occasionally	7 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Week 3 · Frequently	2 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Week 3 · Almost constantly	0 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Year 1 · Never	11 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Year 1 · Rarely	5 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Year 1 · Occasionally	3 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Year 1 · Frequently	0 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Year 1 · Almost constantly	0 Participants

SECONDARY outcome

Timeframe: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing the SEVERITY of participants' Pain in the Abdomen (Belly Area) at its WORST in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).

Outcome measures

Outcome measures
Measure	Treatment (Hypo-fractionated Radiotherapy) n=20 Participants Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Week 3 · None	5 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Week 3 · Mild	9 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Week 3 · Moderate	3 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Week 3 · Severe	2 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Week 3 · Very severe	1 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Year 1 · None	13 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Year 1 · Mild	4 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Year 1 · Moderate	2 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Year 1 · Severe	0 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Year 1 · Very severe	0 Participants

SECONDARY outcome

Timeframe: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing how much Pain in the Abdomen (Belly Area) INTERFERED with their usual or daily activities in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).

Outcome measures

Outcome measures
Measure	Treatment (Hypo-fractionated Radiotherapy) n=20 Participants Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Week 3 · Not at all	10 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Week 3 · A little bit	2 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Week 3 · Somewhat	6 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Week 3 · Quite a bit	1 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Week 3 · Very much	1 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Year 1 · Not at all	16 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Year 1 · A little bit	3 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Year 1 · Somewhat	0 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Year 1 · Quite a bit	0 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Year 1 · Very much	0 Participants

SECONDARY outcome

Timeframe: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing how OFTEN participants experienced Lose Control of Bowel Movement in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).

Outcome measures

Outcome measures
Measure	Treatment (Hypo-fractionated Radiotherapy) n=20 Participants Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Week 3 · Never	6 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Week 3 · Rarely	6 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Week 3 · Occasionally	6 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Week 3 · Frequently	2 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Week 3 · Almost constantly	0 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Year 1 · Never	13 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Year 1 · Rarely	3 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Year 1 · Occasionally	1 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Year 1 · Frequently	2 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Year 1 · Almost constantly	0 Participants

SECONDARY outcome

Timeframe: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing how much Loss of Control of Bowel Movement Interfere INTERFERED with their usual or daily activities in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).

Outcome measures

Outcome measures
Measure	Treatment (Hypo-fractionated Radiotherapy) n=20 Participants Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Interfere Week 3 · Somewhat	7 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Interfere Week 3 · Not at all	9 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Interfere Week 3 · A little bit	3 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Interfere Week 3 · Quite a bit	1 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Interfere Week 3 · Very much	0 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Interfere Year 1 · Not at all	14 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Interfere Year 1 · A little bit	3 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Interfere Year 1 · Somewhat	0 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Interfere Year 1 · Quite a bit	2 Participants
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Interfere Year 1 · Very much	0 Participants

SECONDARY outcome

Timeframe: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To assess acute and 1 year quality of life following treatment as assessed on the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx). FACT-Cx is a 42-item, self-assessed questionnaire rated on a 5-point Likert scale. FACT-Cx total scores range from 0-168, with higher scores indicating better Quality of Life (QOL) and lower scores indicating worse QOL This outcome measure will report the mean change in the FACT-Cx Total Score at the week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) timpoints. A positive change indicates the scores increased (improved QOL), and a negative Change indicates the scores decreased (worse QOL).

Outcome measures

Outcome measures
Measure	Treatment (Hypo-fractionated Radiotherapy) n=20 Participants Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Change in Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) Week 3 Change	-4.80 score on a scale Interval -9.33 to -0.28
Change in Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) Year 1 Change	5.30 score on a scale Interval 0.41 to 10.18

SECONDARY outcome

Timeframe: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To assess acute and 1 year quality of life following treatment as assessed on the FACIT Measure of Financial Toxicity (FACIT-COST). FACT-COST is a 12-item, self-assessed questionnaire rated on a 5-point Likert scale. FACT-COST Score ranges from 0-44, with higher scores indicating better financial well-being and lower scores indicating worse financial well-being. This outcome measure will report the mean change in the FACT-COST Score at the week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) time points. A positive change indicates the scores increased (better financial well-being), and a negative Change indicates the scores decreased (worse financial well-being).

Outcome measures

Outcome measures
Measure	Treatment (Hypo-fractionated Radiotherapy) n=20 Participants Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Change in FACIT Measure of Financial Toxicity (FACIT-COST) Score Week 3	0.95 score on a scale Interval -3.1 to 5.0
Change in FACIT Measure of Financial Toxicity (FACIT-COST) Score Year 1	1.6 score on a scale Interval -1.94 to 5.15

SECONDARY outcome

Timeframe: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)

To assess acute and 1 year satisfaction with decision-making following treatment. The Decision Regret Scale is a 5-item, self-assessed questionnaire rated on a 5-point Likert scale. Decision Regret Scale Score ranges from 0-100, with higher scores indicating high regret and lower scores indicating less regret. This outcome measure will report the mean Decision Regret Scale Score at the week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) time points.

Outcome measures

Outcome measures
Measure	Treatment (Hypo-fractionated Radiotherapy) n=20 Participants Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Decision Regret Scale - Summary Score Week 3	8.16 score on a scale Interval 2.85 to 13.47
Decision Regret Scale - Summary Score Year 1	7.37 score on a scale Interval 2.91 to 11.83

SECONDARY outcome

Timeframe: Time to the earliest of all-cause mortality (event), end of study follow-up (censoring criteria), or loss to follow-up (censoring criteria), assessed up to 3 years

Will use the Kaplan-Meier method to estimate overall survival throughout three years from the time of completing treatment.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Hypo-fractionated Radiotherapy)

Serious events: 4 serious events

Other events: 22 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Hypo-fractionated Radiotherapy) n=22 participants at risk Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Investigations Alanine aminotransferase increased	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Investigations Alkaline phosphatase increased	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Investigations Aspartate aminotransferase increased	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Investigations Blood bilirubin increased	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Gastrointestinal disorders Colitis	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Injury, poisoning and procedural complications Fall	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Gastrointestinal disorders Nausea	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Reproductive system and breast disorders Pelvic pain	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Surgical and medical procedures Surgical and medical procedures - Other, specify	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Gastrointestinal disorders Vomiting	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.

Other adverse events

Other adverse events
Measure	Treatment (Hypo-fractionated Radiotherapy) n=22 participants at risk Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
General disorders Fatigue	59.1% 13/22 • Number of events 15 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Gastrointestinal disorders Fecal incontinence	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Gastrointestinal disorders Flatulence	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
General disorders Flu like symptoms	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Gastrointestinal disorders Gastrointestinal pain	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Nervous system disorders Headache	13.6% 3/22 • Number of events 3 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Vascular disorders Hot flashes	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Gastrointestinal disorders Nausea	59.1% 13/22 • Number of events 13 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
General disorders Pain	13.6% 3/22 • Number of events 3 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Reproductive system and breast disorders Pelvic pain	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Nervous system disorders Peripheral motor neuropathy	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Skin and subcutaneous tissue disorders Pruritus	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Renal and urinary disorders Renal and urinary disorders - Other, specify	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Infections and infestations Sinusitis	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Gastrointestinal disorders Stomach pain	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Renal and urinary disorders Urinary frequency	13.6% 3/22 • Number of events 3 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Renal and urinary disorders Urinary tract pain	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Renal and urinary disorders Urinary urgency	27.3% 6/22 • Number of events 6 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Ear and labyrinth disorders Vertigo	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Gastrointestinal disorders Vomiting	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Gastrointestinal disorders Abdominal pain	18.2% 4/22 • Number of events 4 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Investigations Alkaline phosphatase increased	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Metabolism and nutrition disorders Anorexia	9.1% 2/22 • Number of events 2 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Musculoskeletal and connective tissue disorders Back pain	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Gastrointestinal disorders Constipation	9.1% 2/22 • Number of events 2 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Gastrointestinal disorders Diarrhea	95.5% 21/22 • Number of events 29 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Nervous system disorders Dizziness	13.6% 3/22 • Number of events 3 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Gastrointestinal disorders Dyspepsia	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Renal and urinary disorders Dysuria	13.6% 3/22 • Number of events 4 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.
Skin and subcutaneous tissue disorders Erythroderma	4.5% 1/22 • Number of events 1 • AEs and SAEs will be recorded from the initiation of study treatment until 30 days after the last dose of study treatment, up to 13 months. All-cause survival will be followed throughout 3 years of post study-treatment follow-up, up to 4 years.

Additional Information

IIT Data Management Team

Research Compliance Office, Huntsman Cancer Institute

Phone: 801-213-6215

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place