Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Thera… (NCT01349322) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery
United States2,354 participantsStarted 2011-05-24
Plain-language summary
RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Pathologically proven diagnosis of breast cancer resected by lumpectomy and whole breast irradiation with boost without regional nodal irradiation planned
✓. The patient must be female
✓. The patient must meet at least one of the three following criteria:
✓. Study entry must be within 50 days from whichever comes later: last surgery (breast or axilla) or last chemotherapy. The day of surgery is Day "0".
✓. If multifocal breast cancer, then it must have been resected through a single lumpectomy incision with negative margins
✓. Breast-conserving surgery with margins defined as follows: (also see 3.1.3 for eligibility)
✓. For invasive breast cancer the axilla must be staged by one of the following:
✓. Age ≥ 18
Exclusion criteria
✕. American Joint Committee on Cancer (AJCC) pathologic T4, N2 or N3, M1 pathologic stages III or IV breast cancer
What they're measuring
1
Percentage of Participants With In-breast Recurrence (Local Failure)
Timeframe: From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are reported here.
✕. Treatment plan that includes regional node irradiation
✕. Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry
✕. Prior invasive or in-situ carcinoma of the breast \[-prior lobular carcinoma in situ (LCIS) is eligible\]
✕. Two or more breast cancers not resectable through a single lumpectomy incision
✕. Bilateral breast cancer
✕. DCIS only (without an invasive component) and age ≥ 50 years
✕. DCIS nuclear grade 1 or 2 only (without an invasive component) and age \< 50 years