Resource-sparing Post-mastectomy Radiotherapy in Breast Cancer
NCT01452672 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600
Last updated 2011-10-17
Summary
This study compares two different field set-ups in patients with breast cancer following a breast resection (mastectomy). These two set-ups are as follows: arm a - radiotherapy to the chest-wall only, and arm b - radiotherapy to the chest-wall and the supraclavicular fossa.
Patients in both treatment arms will receive radiotherapy with a shortened fractionation schedule.
Study hypothesis: irradiation of the chest-wall only is not inferior to irradiation of the chest-wall and supraclavicular fossa in terms of loco-regional control, survival and treatment toxicity.
Conditions
Interventions
- RADIATION
-
Radiotherapy
RT 40 Gy in 15 fractions
- RADIATION
-
Irradiation of the chest-wall and supraclavicular fossa
RT 40Gy in 15 fractions
Sponsors & Collaborators
-
International Network for Cancer Treatment and Research
collaborator OTHER -
International Atomic Energy Agency
lead OTHER_GOV
Principal Investigators
-
Eduardo Rosenblatt, MD · International Atomic Energy Agency
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 81 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-03-31
- Primary Completion
- 2012-12-31
- Completion
- 2012-12-31
Countries
- Cuba
- Egypt
- Ghana
- Morocco
- Nigeria
- Pakistan
- Peru
- Turkey (Türkiye)
Study Locations
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