Trial Outcomes & Findings for Hypofractionated Boost Before Chemoradiation for Patients With Stage II-III Non-small Cell Lung Cancer Unsuitable for Surgery (NCT NCT02262325)
NCT ID: NCT02262325
Last Updated: 2025-06-12
Results Overview
Primary tumor control rate at 12 months, as well its 95% confidence interval, will be reported for all eligible subjects received treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
At 12 months following chemo/radiation therapy
Results posted on
2025-06-12
Participant Flow
Participant milestones
| Measure |
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
Death
|
16
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Hypofractionated Boost Before Chemoradiation for Patients With Stage II-III Non-small Cell Lung Cancer Unsuitable for Surgery
Baseline characteristics by cohort
| Measure |
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
n=21 Participants
Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At 12 months following chemo/radiation therapyPrimary tumor control rate at 12 months, as well its 95% confidence interval, will be reported for all eligible subjects received treatment.
Outcome measures
| Measure |
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
n=21 Participants
Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Primary Tumor Control Rate, as Measured From the Time of Treatment Completion Until the First Documented Date of Local Failure
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 30 days after completion of treatment, up to 5 yearsNumber of all adverse events with special attention to grade 3-5 esophagitis, pneumonitis, and cardiac adverse events as defined by the National Cancer Institution Common Terminology Criteria for Adverse Events CTCAE version 5.0
Outcome measures
| Measure |
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
n=21 Participants
Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Number of Adverse Events
Abdominal Pain
|
2 Number of Events
|
|
Number of Adverse Events
Activated partial thromboplastin time prolonged
|
1 Number of Events
|
|
Number of Adverse Events
Acute kidney injury
|
1 Number of Events
|
|
Number of Adverse Events
Adrenal insufficiency
|
1 Number of Events
|
|
Number of Adverse Events
Alanine aminotransferase increased
|
2 Number of Events
|
|
Number of Adverse Events
Alopecia
|
11 Number of Events
|
|
Number of Adverse Events
Anemia
|
14 Number of Events
|
|
Number of Adverse Events
Anorexia
|
7 Number of Events
|
|
Number of Adverse Events
Aortic valve disease
|
1 Number of Events
|
|
Number of Adverse Events
Arthralgia
|
1 Number of Events
|
|
Number of Adverse Events
Aspartate aminotransferase increased
|
3 Number of Events
|
|
Number of Adverse Events
Bloating
|
1 Number of Events
|
|
Number of Adverse Events
Blood and lymphatic system disorders- Other, coagulation
|
1 Number of Events
|
|
Number of Adverse Events
Blurred vision
|
1 Number of Events
|
|
Number of Adverse Events
Bronchial infection
|
1 Number of Events
|
|
Number of Adverse Events
Bronchial obstruction
|
1 Number of Events
|
|
Number of Adverse Events
Bronchial stricture
|
1 Number of Events
|
|
Number of Adverse Events
Bruising- Lt rib area
|
1 Number of Events
|
|
Number of Adverse Events
Chest wall pain
|
1 Number of Events
|
|
Number of Adverse Events
Chills
|
1 Number of Events
|
|
Number of Adverse Events
Confusion
|
1 Number of Events
|
|
Number of Adverse Events
Constipation
|
6 Number of Events
|
|
Number of Adverse Events
Cough, intermittent
|
4 Number of Events
|
|
Number of Adverse Events
Cushingoid, face
|
1 Number of Events
|
|
Number of Adverse Events
Dehydration
|
7 Number of Events
|
|
Number of Adverse Events
Dermatitis Radiation (to upper back and skin darkening to the underside of right breast)
|
15 Number of Events
|
|
Number of Adverse Events
Diarrhea
|
6 Number of Events
|
|
Number of Adverse Events
Dizziness
|
6 Number of Events
|
|
Number of Adverse Events
Dysgeusia
|
1 Number of Events
|
|
Number of Adverse Events
Dyspepsia
|
2 Number of Events
|
|
Number of Adverse Events
Dysphagia
|
14 Number of Events
|
|
Number of Adverse Events
Dyspnea
|
7 Number of Events
|
|
Number of Adverse Events
Dyspnea and cough
|
3 Number of Events
|
|
Number of Adverse Events
Ear and labyrinth disorders- Other, Chronic otomastoiditis- bilateral
|
1 Number of Events
|
|
Number of Adverse Events
Epistaxis
|
1 Number of Events
|
|
Number of Adverse Events
Esophageal pain- odynophagia
|
3 Number of Events
|
|
Number of Adverse Events
Esophageal stenosis
|
1 Number of Events
|
|
Number of Adverse Events
Esophagitis
|
14 Number of Events
|
|
Number of Adverse Events
Fall
|
1 Number of Events
|
|
Number of Adverse Events
Fever (Max 100.8)
|
2 Number of Events
|
|
Number of Adverse Events
Fibrosis deep connective tissue
|
1 Number of Events
|
|
Number of Adverse Events
Flushing
|
1 Number of Events
|
|
Number of Adverse Events
Fracture- left rib
|
1 Number of Events
|
|
Number of Adverse Events
Gastritis
|
1 Number of Events
|
|
Number of Adverse Events
Gastroesophageal reflux disease (GERD)
|
2 Number of Events
|
|
Number of Adverse Events
Gastrointestinal disorders- Other- Perirectal abscess
|
2 Number of Events
|
|
Number of Adverse Events
Headache
|
2 Number of Events
|
|
Number of Adverse Events
Hematuria
|
2 Number of Events
|
|
Number of Adverse Events
Hiccups
|
3 Number of Events
|
|
Number of Adverse Events
Hoarseness
|
1 Number of Events
|
|
Number of Adverse Events
Hyperglycemia
|
2 Number of Events
|
|
Number of Adverse Events
Hyperkalemia
|
1 Number of Events
|
|
Number of Adverse Events
Hypernatremia
|
1 Number of Events
|
|
Number of Adverse Events
Hyperpigmentation- left chest (red discoloration)
|
2 Number of Events
|
|
Number of Adverse Events
Hypertension- intermittent
|
3 Number of Events
|
|
Number of Adverse Events
Hypoalbuminemia
|
2 Number of Events
|
|
Number of Adverse Events
Hypocalcemia (uncorrected- 8.3)
|
2 Number of Events
|
|
Number of Adverse Events
Hypokalemia (3.3)
|
5 Number of Events
|
|
Number of Adverse Events
Hypomagnesemia (1.5)
|
4 Number of Events
|
|
Number of Adverse Events
Hyponatremia
|
2 Number of Events
|
|
Number of Adverse Events
Hypophosphatemia
|
1 Number of Events
|
|
Number of Adverse Events
Hypotension- orthostatic
|
1 Number of Events
|
|
Number of Adverse Events
Hypothyroidism
|
1 Number of Events
|
|
Number of Adverse Events
Hypoxia
|
1 Number of Events
|
|
Number of Adverse Events
Infections and infestations- Other- Bacteremia
|
2 Number of Events
|
|
Number of Adverse Events
Infusion related reaction during Paclitaxel infusion
|
2 Number of Events
|
|
Number of Adverse Events
Infusion site reaction- right forearm- General disorders other
|
2 Number of Events
|
|
Number of Adverse Events
Insomnia
|
1 Number of Events
|
|
Number of Adverse Events
Localized edema- left chest wall
|
1 Number of Events
|
|
Number of Adverse Events
Lung infection-pneumonia
|
5 Number of Events
|
|
Number of Adverse Events
Lymphocyte Count Decreased
|
19 Number of Events
|
|
Number of Adverse Events
Mucosal infection- mouth thrush
|
2 Number of Events
|
|
Number of Adverse Events
Musculoskeletal and connective tissue disorder- Other, right paraspinal muscle spasm
|
2 Number of Events
|
|
Number of Adverse Events
Mucositis oral- mouth sore
|
3 Number of Events
|
|
Number of Adverse Events
Myalgia
|
1 Number of Events
|
|
Number of Adverse Events
Nasal congestion
|
1 Number of Events
|
|
Number of Adverse Events
Nausea
|
10 Number of Events
|
|
Number of Adverse Events
Nervous system disorders- Other, increased sense of smell, intermittent
|
4 Number of Events
|
|
Number of Adverse Events
Neutrophil count decreased
|
9 Number of Events
|
|
Number of Adverse Events
Non-cardiac chest pain
|
4 Number of Events
|
|
Number of Adverse Events
Pain in extremity- both hands due to arthritis
|
2 Number of Events
|
|
Number of Adverse Events
Pain- back
|
2 Number of Events
|
|
Number of Adverse Events
Pain-ribs
|
1 Number of Events
|
|
Number of Adverse Events
Palpitation
|
1 Number of Events
|
|
Number of Adverse Events
Paresthesia- both lower extremities
|
1 Number of Events
|
|
Number of Adverse Events
Pericardial effusion
|
2 Number of Events
|
|
Number of Adverse Events
Peripheral motor neuropathy
|
2 Number of Events
|
|
Number of Adverse Events
Peripheral sensory neuropathy
|
4 Number of Events
|
|
Number of Adverse Events
Platelet count decreased
|
11 Number of Events
|
|
Number of Adverse Events
Pleural effusion
|
5 Number of Events
|
|
Number of Adverse Events
Pleuritic pain, intermittent (Rt below breast)
|
1 Number of Events
|
|
Number of Adverse Events
Pneumonitis, radiation related
|
8 Number of Events
|
|
Number of Adverse Events
Productive cough
|
7 Number of Events
|
|
Number of Adverse Events
Proteinuria
|
1 Number of Events
|
|
Number of Adverse Events
Pruritis (back)
|
1 Number of Events
|
|
Number of Adverse Events
Pulmonary fibrosis
|
9 Number of Events
|
|
Number of Adverse Events
Rash- maculo-papular- back/chest
|
3 Number of Events
|
|
Number of Adverse Events
Respiratory failure
|
1 Number of Events
|
|
Number of Adverse Events
Respiratory, mediastinal and thoracic disorders- Other- COPD
|
4 Number of Events
|
|
Number of Adverse Events
Sebaceous cyst on the back
|
3 Number of Events
|
|
Number of Adverse Events
Sepsis
|
1 Number of Events
|
|
Number of Adverse Events
Sinus bradycardia
|
1 Number of Events
|
|
Number of Adverse Events
Sinus tachycardia
|
2 Number of Events
|
|
Number of Adverse Events
Skin infection- gluteal cleft
|
2 Number of Events
|
|
Number of Adverse Events
Sore throat
|
3 Number of Events
|
|
Number of Adverse Events
Syncope
|
1 Number of Events
|
|
Number of Adverse Events
Tachycardia- intermittent
|
3 Number of Events
|
|
Number of Adverse Events
Tinnitus- both ears
|
2 Number of Events
|
|
Number of Adverse Events
Tremor
|
1 Number of Events
|
|
Number of Adverse Events
Upper respiratory infection
|
2 Number of Events
|
|
Number of Adverse Events
Urinary Tract Infection- Pyelonephritis
|
2 Number of Events
|
|
Number of Adverse Events
Vomiting- intermittent
|
9 Number of Events
|
|
Number of Adverse Events
Weight gain
|
1 Number of Events
|
|
Number of Adverse Events
Weight loss
|
7 Number of Events
|
|
Number of Adverse Events
Wheezing
|
6 Number of Events
|
|
Number of Adverse Events
White blood cell count decreased
|
17 Number of Events
|
|
Number of Adverse Events
Fatigue
|
11 Number of Events
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe number of patients who discontinue treatment will be summarized.
Outcome measures
| Measure |
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
n=21 Participants
Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Tolerability Measured by the Number of Patients Who Discontinue Treatment
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsRegional control rate at 24 months will be reported for all eligible patients who received treatment.
Outcome measures
| Measure |
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
n=21 Participants
Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Regional Control
|
81.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsDistant control rate at 24 months will be reported for all eligible patients who received treatment
Outcome measures
| Measure |
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
n=21 Participants
Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Distant Control
|
70.3 percentage of participants
|
SECONDARY outcome
Timeframe: From date of treatment initiation to progression, assessed up to 24 monthsKaplan-Meier (K-M) analysis will be used to estimate DFS.
Outcome measures
| Measure |
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
n=21 Participants
Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Disease-free Survival (DFS)
|
46.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsK-M analysis will be used to estimate OS.
Outcome measures
| Measure |
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
n=21 Participants
Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Survival (OS)
|
50.3 percentage of participants
|
SECONDARY outcome
Timeframe: At 3 months and 6 monthsObjective response rate will be reported for all eligible patients who receive treatment.
Outcome measures
| Measure |
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
n=21 Participants
Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Objective Response Rate as Measured by Response Evaluation Criteria in Solid Tumors Criteria
At 3 months
|
72.7 percentage of participants
|
|
Objective Response Rate as Measured by Response Evaluation Criteria in Solid Tumors Criteria
At 6 months
|
80.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to the end of week 1Population: The functional MRI substudies that measured changes in tumor perfusion were optional for participants. Eleven participants chose to participate in the substudies.
Changes in perfusion will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test. The following pharmacokinetic parameters will be used (parameters were derived using the modified Brix's model): Amp, Kep.
Outcome measures
| Measure |
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
n=11 Participants
Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Changes in Tumor Perfusion Measured by MR-DCE/PWI Amp and Kep
Changes in Kep
|
2.9 percentage of change
Standard Deviation 47
|
|
Changes in Tumor Perfusion Measured by MR-DCE/PWI Amp and Kep
Changes in Amp
|
-6.8 percentage of change
Standard Deviation 22.9
|
SECONDARY outcome
Timeframe: Baseline to the end of week 1Population: The functional MRI substudies that measured changes in tumor perfusion were optional for participants. Eleven participants chose to participate in the substudies.
Changes in perfusion will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test. The following pharmacokinetic parameters will be used (parameters were derived using the modified Brix's model): Kpe, Kel.
Outcome measures
| Measure |
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
n=11 Participants
Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Changes in Tumor Perfusion Measured by MR-DCE/PWI Kpe and Kel
Changes in Kpe
|
5.1 percentage of change
Interval -11.1 to 24.6
|
|
Changes in Tumor Perfusion Measured by MR-DCE/PWI Kpe and Kel
Changes in Kel
|
-4.5 percentage of change
Interval -87.0 to 75.0
|
SECONDARY outcome
Timeframe: Baseline to the end of week 1Population: The functional MRI substudies that measured changes in tumor perfusion were optional for participants. Eleven participants chose to participate in the substudies.
Changes in diffusion will be tested by comparing mean values of Apparent Diffusion Coefficient (ADC \[× 10-3 mm2/s\]) pre- and post-hypofractionated boost radiation using a paired t-test.
Outcome measures
| Measure |
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
n=11 Participants
Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Changes in Diffusion Measured by MR-diffusion
|
23 percentage of change
Standard Deviation 52.4
|
SECONDARY outcome
Timeframe: Baseline to the end of week 1Population: The functional MRI substudies that measured changes in tumor perfusion were optional for participants. Eleven participants chose to participate in the substudies.
Changes in hypoxia will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test.
Outcome measures
| Measure |
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
n=11 Participants
Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Changes in Hypoxia Measured by BOLD Sequences
|
-87.1 percentage of change
Standard Deviation 144.7
|
Adverse Events
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
Serious events: 9 serious events
Other events: 21 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
n=21 participants at risk
Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Psychiatric disorders
Depression
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Nervous system disorders
Encephalopathy
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
General disorders
Fall
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Gastrointestinal disorders
Perirectal Abscess
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Vascular disorders
Hypotenstion- orthostatic
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Infections and infestations
Kidney Infection
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Infections and infestations
Lung Infection - pneumonia
|
9.5%
2/21 • Number of events 2 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Hernia just superior to umbilicus
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
General disorders
Non-cardiac chest pain
|
9.5%
2/21 • Number of events 2 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis, radiation related
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease (COPD)
|
19.0%
4/21 • Number of events 4 • up to 5 years
|
|
Infections and infestations
Sepsis
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Nervous system disorders
Syncope
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Vascular disorders
Thromboembolic event, Bilateral lower extremity deep vein thrombosis
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Infections and infestations
Urinary tract infection - pyelonephritis
|
9.5%
2/21 • Number of events 2 • up to 5 years
|
|
Vascular disorders
Atherosclerosis
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
Other adverse events
| Measure |
Treatment (Hypofractionated Radiation Boost, Chemoradiation)
n=21 participants at risk
Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
19.0%
4/21 • Number of events 4 • up to 5 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
9.5%
2/21 • Number of events 2 • up to 5 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
9.5%
2/21 • Number of events 2 • up to 5 years
|
|
Endocrine disorders
Adrenal insufficiency
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
9.5%
2/21 • Number of events 2 • up to 5 years
|
|
Investigations
Alkaline phosphatase increased
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Immune system disorders
Allergic reaction to an elastic bandage wrap
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
52.4%
11/21 • Number of events 11 • up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
85.7%
18/21 • Number of events 18 • up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
7/21 • Number of events 7 • up to 5 years
|
|
Cardiac disorders
Aortic Valve Disease
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
3/21 • Number of events 3 • up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
19.0%
4/21 • Number of events 4 • up to 5 years
|
|
Gastrointestinal disorders
Bloating
|
4.8%
1/21 • Number of events 1 • up to 5 years
|
|
Blood and lymphatic system disorders
Coagulation
|
9.5%
2/21 • Number of events 2 • up to 5 years
|
|
Eye disorders
Blurred vision
|
19.0%
4/21 • Number of events 4 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
14.3%
3/21 • Number of events 3 • up to 5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
19.0%
4/21 • Number of events 4 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
9.5%
2/21 • Number of events 2 • up to 5 years
|
|
General disorders
Chills
|
19.0%
4/21 • Number of events 4 • up to 5 years
|
|
Psychiatric disorders
Confusion
|
9.5%
2/21 • Number of events 2 • up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
52.4%
11/21 • Number of events 11 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough, intermittent
|
33.3%
7/21 • Number of events 7 • up to 5 years
|
|
Investigations
Creatinine increased
|
23.8%
5/21 • Number of events 5 • up to 5 years
|
|
Endocrine disorders
Cushingoid, face
|
9.5%
2/21 • Number of events 2 • up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
7/21 • Number of events 7 • up to 5 years
|
|
Psychiatric disorders
Depression
|
19.0%
4/21 • Number of events 4 • up to 5 years
|
|
Injury, poisoning and procedural complications
Dermatitis Radiation
|
71.4%
15/21 • Number of events 15 • up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
38.1%
8/21 • Number of events 8 • up to 5 years
|
|
Nervous system disorders
Dizziness
|
42.9%
9/21 • Number of events 9 • up to 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
9.5%
2/21 • Number of events 2 • up to 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
66.7%
14/21 • Number of events 14 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
52.4%
11/21 • Number of events 11 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea and cough
|
23.8%
5/21 • Number of events 5 • up to 5 years
|
|
Ear and labyrinth disorders
Chronic otomastoiditis - bilateral
|
9.5%
2/21 • Number of events 2 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.5%
2/21 • Number of events 2 • up to 5 years
|
|
Gastrointestinal disorders
Esophageal pain - odynophagia
|
14.3%
3/21 • Number of events 3 • up to 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
66.7%
14/21 • Number of events 14 • up to 5 years
|
|
Eye disorders
Vision Change
|
9.5%
2/21 • Number of events 2 • up to 5 years
|
|
General disorders
Fall
|
9.5%
2/21 • Number of events 2 • up to 5 years
|
Additional Information
Dr. Eric Miller
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-8595
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place