Trial Outcomes & Findings for Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor (NCT NCT01000662)
NCT ID: NCT01000662
Last Updated: 2020-08-06
Results Overview
Number of patients with a grade 2 or greater toxicity after 3 weeks of whole breast IMRT with a once/week boost compared to those patients treated with a daily boost: 0 - no symptoms, 5 - death directly related to radiation effects
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
412 participants
Primary outcome timeframe
Day 60
Results posted on
2020-08-06
Participant Flow
Participant milestones
| Measure |
ARM 1 Daily Boost
Radiation Therapy
15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
|
ARM 2 Weekly Boost
Radiation Therapy
15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
|---|---|---|
|
Overall Study
STARTED
|
206
|
206
|
|
Overall Study
COMPLETED
|
202
|
198
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor
Baseline characteristics by cohort
| Measure |
ARM 1 Daily Boost
n=206 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
ARM 2 Weekly Boost
n=206 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
Total
n=412 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
155 Participants
n=93 Participants
|
168 Participants
n=4 Participants
|
323 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
51 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
206 Participants
n=93 Participants
|
206 Participants
n=4 Participants
|
412 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
158 Participants
n=93 Participants
|
150 Participants
n=4 Participants
|
308 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
206 participants
n=93 Participants
|
206 participants
n=4 Participants
|
412 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 60Population: Patients receiving either daily or weekly boost to radiation therapy
Number of patients with a grade 2 or greater toxicity after 3 weeks of whole breast IMRT with a once/week boost compared to those patients treated with a daily boost: 0 - no symptoms, 5 - death directly related to radiation effects
Outcome measures
| Measure |
ARM 1 Daily Boost
n=202 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
ARM 2 Weekly Boost
n=198 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
|---|---|---|
|
Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)
|
22 participants
|
16 participants
|
SECONDARY outcome
Timeframe: BaselineBCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = "No difference"; 2 = "Slight"; 3 = "Moderate"; 4 = "Large difference". The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.
Outcome measures
| Measure |
ARM 1 Daily Boost
n=202 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
ARM 2 Weekly Boost
n=198 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
|---|---|---|
|
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline
Functional Status
|
6.89 score on a scale
Standard Deviation 2.72
|
7.03 score on a scale
Standard Deviation 2.74
|
|
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline
Cosmetic Status
|
9.71 score on a scale
Standard Deviation 3.2
|
9.9 score on a scale
Standard Deviation 3.32
|
|
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline
Breast Specific Pain
|
3.69 score on a scale
Standard Deviation 1.28
|
3.87 score on a scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: BaselineSF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or "vitality," at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = "All of the time"; 2 = "Most of the time"; 3 = "Some of the time"; 4 = "A little of the time"; 5 = "None of the time".
Outcome measures
| Measure |
ARM 1 Daily Boost
n=202 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
ARM 2 Weekly Boost
n=198 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
|---|---|---|
|
Score on "SF-36 v2 Vitality" Scale
Good Feeling
|
2.56 score on a scale
Standard Deviation 0.91
|
2.65 score on a scale
Standard Deviation 0.95
|
|
Score on "SF-36 v2 Vitality" Scale
Bad Feeling
|
3.3 score on a scale
Standard Deviation 0.88
|
3.3 score on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: BaselineThe BPI is a self-administered assessment tool used in pain management. The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain The total range is 1-10; the higher the score, the higher the pain level.
Outcome measures
| Measure |
ARM 1 Daily Boost
n=202 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
ARM 2 Weekly Boost
n=198 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
|---|---|---|
|
Average Score on Brief Pain Inventory (BPI) Scale
|
1.46 score on a scale
Standard Deviation 1.59
|
1.71 score on a scale
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: Baseline4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor." The total range is 1-4; the higher the score, the lower the breast quality.
Outcome measures
| Measure |
ARM 1 Daily Boost
n=202 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
ARM 2 Weekly Boost
n=198 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
|---|---|---|
|
Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale
Satisfaction on Breast Looks
|
1.97 score on a scale
Standard Deviation 0.78
|
1.96 score on a scale
Standard Deviation 0.84
|
|
Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale
Satisfaction about Treatment
|
1.47 score on a scale
Standard Deviation 0.78
|
1.41 score on a scale
Standard Deviation 0.71
|
|
Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale
Convenience of Care
|
2.53 score on a scale
Standard Deviation 2.38
|
2.84 score on a scale
Standard Deviation 2.41
|
SECONDARY outcome
Timeframe: At the end of Treatment, an average of 3 weeksBCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = "No difference"; 2 = "Slight"; 3 = "Moderate"; 4 = "Large difference". The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.
Outcome measures
| Measure |
ARM 1 Daily Boost
n=202 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
ARM 2 Weekly Boost
n=198 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
|---|---|---|
|
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment
Breast Specific Pain
|
4.57 score on a scale
Standard Deviation 1.34
|
4.51 score on a scale
Standard Deviation 1.51
|
|
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment
Functional Status
|
7.08 score on a scale
Standard Deviation 2.72
|
7.56 score on a scale
Standard Deviation 3.24
|
|
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment
Cosmetic Status
|
10.29 score on a scale
Standard Deviation 3.17
|
10.10 score on a scale
Standard Deviation 3.11
|
SECONDARY outcome
Timeframe: 45-60 days after treatmentBCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = "No difference"; 2 = "Slight"; 3 = "Moderate"; 4 = "Large difference". The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.
Outcome measures
| Measure |
ARM 1 Daily Boost
n=202 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
ARM 2 Weekly Boost
n=198 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
|---|---|---|
|
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS)
Breast Specific Pain
|
3.94 score on a scale
Standard Deviation 1.34
|
3.80 score on a scale
Standard Deviation 1.40
|
|
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS)
Functional Status
|
6.93 score on a scale
Standard Deviation 3.13
|
7.01 score on a scale
Standard Deviation 2.79
|
|
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS)
Cosmetic Status
|
10.17 score on a scale
Standard Deviation 3.07
|
10.00 score on a scale
Standard Deviation 2.84
|
SECONDARY outcome
Timeframe: End of TreatmentSF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or "vitality," at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = "All of the time"; 2 = "Most of the time"; 3 = "Some of the time"; 4 = "A little of the time"; 5 = "None of the time".
Outcome measures
| Measure |
ARM 1 Daily Boost
n=202 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
ARM 2 Weekly Boost
n=198 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
|---|---|---|
|
Score on "SF-36 v2 Vitality" Scale
Good Feeling
|
2.55 score on a scale
Standard Deviation 0.87
|
3.59 score on a scale
Standard Deviation 0.92
|
|
Score on "SF-36 v2 Vitality" Scale
Bad Feeling
|
3.32 score on a scale
Standard Deviation 0.86
|
3.25 score on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: 45-60 days after treatmentSF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or "vitality," at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = "All of the time"; 2 = "Most of the time"; 3 = "Some of the time"; 4 = "A little of the time"; 5 = "None of the time".
Outcome measures
| Measure |
ARM 1 Daily Boost
n=202 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
ARM 2 Weekly Boost
n=198 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
|---|---|---|
|
Score on "SF-36 v2 Vitality" Scale 45-60 Days After Treatment
Good Feeling
|
2.46 score on a scale
Standard Deviation 0.78
|
2.36 score on a scale
Standard Deviation 0.91
|
|
Score on "SF-36 v2 Vitality" Scale 45-60 Days After Treatment
Bad Feeling
|
3.29 score on a scale
Standard Deviation 0.92
|
3.45 score on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: At the end of Treatment, an average of 3 weeksThe BPI is a self-administered assessment tool used in pain management. The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain The total range is 1-10; the higher the score, the higher the pain level.
Outcome measures
| Measure |
ARM 1 Daily Boost
n=202 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
ARM 2 Weekly Boost
n=198 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
|---|---|---|
|
Average Score on Brief Pain Inventory (BPI)
|
1.46 score on a scale
Standard Deviation 1.59
|
1.66 score on a scale
Standard Deviation 1.67
|
SECONDARY outcome
Timeframe: 45-60 days after treatmentThe BPI is a self-administered assessment tool used in pain management. The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain The total range is 1-10; the higher the score, the higher the pain level.
Outcome measures
| Measure |
ARM 1 Daily Boost
n=202 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
ARM 2 Weekly Boost
n=198 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
|---|---|---|
|
Average Score on Brief Pain Inventory (BPI)
|
1.23 score on a scale
Standard Deviation 1.51
|
1.37 score on a scale
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: End of Treatment4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor"
Outcome measures
| Measure |
ARM 1 Daily Boost
n=202 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
ARM 2 Weekly Boost
n=198 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
|---|---|---|
|
Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment
Breast Looks now
|
2.12 score on a scale
Standard Deviation 0.74
|
1.95 score on a scale
Standard Deviation 0.82
|
|
Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment
Satisfaction about Treatment
|
1.35 score on a scale
Standard Deviation 0.68
|
1.33 score on a scale
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: 45-60 days after treatment4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor."
Outcome measures
| Measure |
ARM 1 Daily Boost
n=202 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
ARM 2 Weekly Boost
n=198 Participants
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
|---|---|---|
|
Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment
Breast Looks now
|
2.02 score on a scale
Standard Deviation 0.73
|
1.94 score on a scale
Standard Deviation 0.76
|
|
Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment
Satisfaction about Treatment
|
1.33 score on a scale
Standard Deviation 0.72
|
1.32 score on a scale
Standard Deviation 0.67
|
Adverse Events
ARM 1 Daily Boost
Serious events: 0 serious events
Other events: 89 other events
Deaths: 0 deaths
ARM 2 Weekly Boost
Serious events: 0 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ARM 1 Daily Boost
n=202 participants at risk
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
ARM 2 Weekly Boost
n=198 participants at risk
Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Edema (Grade 1)
|
3.0%
6/202 • Number of events 6 • Day 1 of radiation therapy to Day 60
|
1.0%
2/198 • Number of events 2 • Day 1 of radiation therapy to Day 60
|
|
Reproductive system and breast disorders
Fibrosis (Grade 1)
|
12.9%
26/202 • Number of events 28 • Day 1 of radiation therapy to Day 60
|
8.6%
17/198 • Number of events 17 • Day 1 of radiation therapy to Day 60
|
|
Reproductive system and breast disorders
Pain (Grade 1)
|
5.0%
10/202 • Number of events 10 • Day 1 of radiation therapy to Day 60
|
6.1%
12/198 • Number of events 12 • Day 1 of radiation therapy to Day 60
|
|
Skin and subcutaneous tissue disorders
Pigmentation Change (Grade 1)
|
7.4%
15/202 • Number of events 18 • Day 1 of radiation therapy to Day 60
|
6.6%
13/198 • Number of events 13 • Day 1 of radiation therapy to Day 60
|
|
Skin and subcutaneous tissue disorders
Retraction/Atrophy (Grade 1)
|
11.4%
23/202 • Number of events 25 • Day 1 of radiation therapy to Day 60
|
11.6%
23/198 • Number of events 23 • Day 1 of radiation therapy to Day 60
|
|
Skin and subcutaneous tissue disorders
Telangiectasia (Grade 1)
|
6.4%
13/202 • Number of events 13 • Day 1 of radiation therapy to Day 60
|
2.0%
4/198 • Number of events 4 • Day 1 of radiation therapy to Day 60
|
|
Blood and lymphatic system disorders
Lymphedema (Grade 1)
|
0.00%
0/202 • Day 1 of radiation therapy to Day 60
|
0.51%
1/198 • Number of events 1 • Day 1 of radiation therapy to Day 60
|
Additional Information
Dr. Silvia Formenti, Chairman, Department of Radiation Oncology
NYU Langone Medical Center
Phone: (212) 731-5039
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place