Randomized Boost Versus no Boost Irradiation of Early Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02295033|
Recruitment Status : Completed
First Posted : November 19, 2014
Last Update Posted : November 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: Boost irradiation||Phase 3|
This is a randomized study. Patients are stratified by participating institution, menopausal status, clinical tumor size, nodal status, presence of Ductal Carcinoma In Situ, age, and resection margin status.
The objective of this trial is to assess the local recurrence rate and the cosmetic result in women who have had conservative resection of small breast cancers and who are randomly assigned after postoperative whole-breast irradiation to no boost vs. 15-16 Gy boost (patients with microscopically complete resections) or 10 Gy vs. 25-26 Gy boost (patients with microscopically incomplete resections).
Following tumorectomy, all patients receive radiotherapy for 5 weeks.
Patients with microscopically negative resection margins are randomized to one of 2 groups: no further radiotherapy; or a radiotherapy boost with either external-beam radiotherapy or an interstitial implant.
Patients with microscopically positive resection margins are also randomized to receive either lower dose or higher dose radiotherapy boosts by external beam or interstitial implant.
Patients with positive lymph nodes are encouraged to receive at least 6 courses of adjuvant or perioperative chemotherapy prior to radiotherapy provided radiotherapy is initiated within 6 months of surgery. All other patients begin radiotherapy within 9 weeks of surgery. All postmenopausal women with positive lymph nodes receive oral tamoxifen daily for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase III Study in the Conservative Management of Breast Carcinoma by Tumorectomy and Radiotherapy: Assessment of the Role of a Booster Dose of Radiotherapy (Joint Study of the European Organisation for Research and Treatment of Cancer Radiotherapy Cooperative Group and Breast Cancer Cooperative Group)|
|Study Start Date :||May 1989|
|Actual Primary Completion Date :||May 2006|
|Experimental: Boost irradiation||
Radiation: Boost irradiation
|No Intervention: No boost irradiation|
- Time to local recurrence [ Time Frame: 25 years from first patient in ]