Trial Outcomes & Findings for Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer (NCT NCT01127373)
NCT ID: NCT01127373
Last Updated: 2021-04-20
Results Overview
The purpose of this pilot study is to assess the feasibility of utilizing multi-beam IMRT in the adjuvant treatment of the breast and regional lymph nodes of women with node-positive breast cancer requiring coverage of the internal mammary lymph nodes. A feasibility rate of at least 90% is required, ie, treatment can be successfully planned and delivered for at least 90% of the patients.
COMPLETED
NA
116 participants
5 weeks
2021-04-20
Participant Flow
Participant milestones
| Measure |
Radiation Therapy Via Multi-beam IMRT
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
|
|---|---|
|
Overall Study
STARTED
|
116
|
|
Overall Study
COMPLETED
|
104
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Radiation Therapy Via Multi-beam IMRT
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
|
|---|---|
|
Overall Study
Not Treated
|
3
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Disease progression
|
1
|
Baseline Characteristics
Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Radiation Therapy Via Multi-beam IMRT
n=116 Participants
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
|
|---|---|
|
Age, Continuous
|
50 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
109 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
14 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
|
15 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
79 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
116 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 5 weeksThe purpose of this pilot study is to assess the feasibility of utilizing multi-beam IMRT in the adjuvant treatment of the breast and regional lymph nodes of women with node-positive breast cancer requiring coverage of the internal mammary lymph nodes. A feasibility rate of at least 90% is required, ie, treatment can be successfully planned and delivered for at least 90% of the patients.
Outcome measures
| Measure |
Radiation Therapy Via Multi-beam IMRT
n=116 Participants
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
|
|---|---|
|
Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification
Completed IMRT
|
111 Participants
|
|
Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification
Ineligible
|
4 Participants
|
|
Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification
Discontinued IMRT due to disease progression
|
1 Participants
|
SECONDARY outcome
Timeframe: 5-7 months following the completion of radiation therapyToxicity evaluated by utilizing the CTCAE version 3.0 grading system.
Outcome measures
| Measure |
Radiation Therapy Via Multi-beam IMRT
n=116 Participants
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
|
|---|---|
|
Number of Participants Evaluated for Acute and Late Cutaneous Toxicity
|
116 Participants
|
SECONDARY outcome
Timeframe: 5-7 months following the completion of radiation therapyThe radiation oncologist will score late subcutaneous fibrosis at 5-7 months following CoT, utilizing the CTCAE version 3.0 grading system.
Outcome measures
| Measure |
Radiation Therapy Via Multi-beam IMRT
n=116 Participants
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
|
|---|---|
|
Number of Participants Evaluated for Late Subcutaneous Fibrosis
Experienced Skin & subcutaneous tissue disorders
|
1 Participants
|
|
Number of Participants Evaluated for Late Subcutaneous Fibrosis
Did not experience skin & subcutaneous tissue diso
|
115 Participants
|
SECONDARY outcome
Timeframe: BaselineParticipants FEV1 (forced expiratory volume in 1 second) measured at baseline
Outcome measures
| Measure |
Radiation Therapy Via Multi-beam IMRT
n=116 Participants
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
|
|---|---|
|
Mean FEV1 at Baseline
|
2.6 liters
Interval 1.2 to 3.9
|
SECONDARY outcome
Timeframe: BaselineSeverity of radiation pneumonitis (RP) measured by FEV1 Z (forced expiratory volume in 1 second) and FVC Z (forced vital capacity) for participants at baseline
Outcome measures
| Measure |
Radiation Therapy Via Multi-beam IMRT
n=116 Participants
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
|
|---|---|
|
Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)
|
80.1 FEV1 / FVC percentage
Interval 57.0 to 93.0
|
SECONDARY outcome
Timeframe: BaselineParticipant Pulmonary Function Test/PFTs and mean Community-Acquired Pneumonia/CAP scores will be taken at baseline and again at 6 months post radiation therapy
Outcome measures
| Measure |
Radiation Therapy Via Multi-beam IMRT
n=116 Participants
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
|
|---|---|
|
Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg)
|
18.5 mL/min/mmHg
Interval 10.0 to 30.0
|
SECONDARY outcome
Timeframe: BaselineMean Community-Acquired Pneumonia/CAP scores will be taken at baseline and again at 6 months post radiation therapy. The questionnaire focuses on the presence of dyspnea, severity of dyspnea, presence of cough, and general health and generates a "CAP score." Low values indicate more severe symptoms. Means will be taken of total scores, from 1-100.
Outcome measures
| Measure |
Radiation Therapy Via Multi-beam IMRT
n=116 Participants
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
|
|---|---|
|
Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score
|
84.8 units on a scale
Interval 33.8 to 100.0
|
SECONDARY outcome
Timeframe: 6 months post radiation therapyParticipant Pulmonary Function Test/PFTs and mean Community-Acquired Pneumonia/CAP scores will be taken at baseline and again at 6 months post radiation therapy
Outcome measures
| Measure |
Radiation Therapy Via Multi-beam IMRT
n=116 Participants
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
|
|---|---|
|
Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)
|
2.6 1 sec/FEV1 (Liters)
Interval 1.0 to 3.69
|
SECONDARY outcome
Timeframe: 6 months post radiation therapySeverity of radiation pneumonitis (RP) measured by FEV1 Z (forced expiratory volume in 1 second) and FVC Z (forced vital capacity) for participants 6 months from baseline.
Outcome measures
| Measure |
Radiation Therapy Via Multi-beam IMRT
n=116 Participants
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
|
|---|---|
|
Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)
|
79.6 FEV1 / FVC percentage
Interval 64.0 to 98.0
|
SECONDARY outcome
Timeframe: 6 months post radiation therapyParticipant Pulmonary Function Test/PFTs and mean Community-Acquired Pneumonia/CAP scores will be taken at baseline and again at 6 months post radiation therapy
Outcome measures
| Measure |
Radiation Therapy Via Multi-beam IMRT
n=116 Participants
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
|
|---|---|
|
Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg)
|
18.8 mL/min/mmHg
Interval 5.0 to 65.0
|
SECONDARY outcome
Timeframe: 6 months post radiation therapyMean Community-Acquired Pneumonia/CAP scores will be taken at 6 months post radiation therapy. The questionnaire focuses on the presence of dyspnea, severity of dyspnea, presence of cough, and general health and generates a "CAP score." Low values indicate more severe symptoms. Means will be taken of total scores, from 1-100.
Outcome measures
| Measure |
Radiation Therapy Via Multi-beam IMRT
n=116 Participants
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
|
|---|---|
|
Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score
|
83.2 units on a scale
Interval 34.4 to 100.0
|
SECONDARY outcome
Timeframe: up to 82 months post-radiation therapyMedian follow-up period of the enrolled cohort
Outcome measures
| Measure |
Radiation Therapy Via Multi-beam IMRT
n=116 Participants
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
|
|---|---|
|
Median Follow-up Period
|
53.4 months
Interval 0.0 to 82.0
|
Adverse Events
Radiation Therapy Via Multi-beam IMRT
Serious adverse events
| Measure |
Radiation Therapy Via Multi-beam IMRT
n=116 participants at risk
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.86%
1/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
Infections and infestations
Breast Infection
|
0.86%
1/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
General disorders
Death not assoc w CTCAE term-Disease prog NOS
|
0.86%
1/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
Nervous system disorders
Dysarthria
|
0.86%
1/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.7%
2/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
General disorders
Fever (in the absence of neutropenia)
|
0.86%
1/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
Skin and subcutaneous tissue disorders
Inf norm ANC/gr1/2 neut-Cellulitis(skin)
|
1.7%
2/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - Whole body/general
|
0.86%
1/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.86%
1/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
0.86%
1/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
General disorders
Pain - Chest/thorax NOS
|
0.86%
1/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.86%
1/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
0.86%
1/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
Nervous system disorders
Seizure
|
1.7%
2/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders Other, spec
|
0.86%
1/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.86%
1/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.86%
1/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
Other adverse events
| Measure |
Radiation Therapy Via Multi-beam IMRT
n=116 participants at risk
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.86%
1/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.86%
1/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis assoc w/ rad-
|
0.86%
1/116 • 5-7 months following the completion of radiation therapy, up to 82 months
|
Additional Information
Dr. Simon Powell, MD
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place