A Phase 3 interventional study of Boost irradiation in Breast Cancer, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed. Open to female participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2014-11-19.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 3, Interventional, and Treatment
Radiation therapy may kill any tumor cells remaining after surgery. This randomized phase III trial is studying the effect of an extra dose of radiation therapy (Boost dose) after breast conserving surgery and 50 Gy adjuvant external beam radiotherapy to see how well it works compared to no further therapy in treating women with early breast cancer that has been surgically removed.
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
Browse Breast Neoplasms studies →European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 352 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Radiation: Boost irradiation
Time to local recurrence
Time frame: 25 years from first patient in
No study locations are listed for this record.
The record gives a start of May 1989 and a primary completion of May 2006. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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