Phase 3
N=412
Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01000662 ↗Enrolled (actual)
412
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG) — 22; 16 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Daily Radiation Therapy (Radiation); Weekly Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- NYU Langone Health
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG) |
22; 16 | — |
| SECONDARY Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline |
6.89; 7.03; 9.71; 9.9; 3.69; 3.87 | — |
| SECONDARY Score on "SF-36 v2 Vitality" Scale |
2.55; 3.59; 3.32; 3.25 | — |
| SECONDARY Average Score on Brief Pain Inventory (BPI) Scale |
1.46; 1.71 | — |
| SECONDARY Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale |
1.97; 1.96; 1.47; 1.41; 2.53; 2.84 | — |
| SECONDARY Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment |
7.08; 7.56; 10.29; 10.10; 4.57; 4.51 | — |
| SECONDARY Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) |
6.93; 7.01; 10.17; 10.00; 3.94; 3.80 | — |
| SECONDARY Score on "SF-36 v2 Vitality" Scale |
2.55; 3.59; 3.32; 3.25 | — |
| SECONDARY Score on "SF-36 v2 Vitality" Scale 45-60 Days After Treatment |
2.46; 2.36; 3.29; 3.45 | — |
| SECONDARY Average Score on Brief Pain Inventory (BPI) |
1.23; 1.37 | — |
| SECONDARY Average Score on Brief Pain Inventory (BPI) |
1.23; 1.37 | — |
| SECONDARY Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment |
2.12; 1.95; 1.35; 1.33 | — |
| SECONDARY Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment |
2.02; 1.94; 1.33; 1.32 | — |
Summary
All patients (with Stages 0-II breast cancer) will receive an accelerated three week regimen of prone whole breast radiotherapy. The study intends to test the hypothesis that a weekly boost to the tumor bed, delivered on Friday, before the weekend break, is as well tolerated as the daily boost during accelerated prone radiotherapy.
Eligibility Criteria
Inclusion Criteria
- Pre or post-menopausal women with stage 0,I, and II breast cancer
- Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
- Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (DCIS and Tumors 3 years
- Pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT01000662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.