Status:
UNKNOWN
Hypofractionated Versus Conventional Fractionation Radiotherapy
Lead Sponsor:
Hospital da Baleia
Conditions:
Breast Cancer
Radiation Toxicity
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study was designed to evaluate the acute toxicity and quality of life of hypofractionated radiation versus conventional when regional node irradiation is indicated after breast-conserving surgery...
Detailed Description
Investigators hypothesize that hypofractionated radiotherapy is equal effective and safe as conventional radiotherapy in breast cancer patients undergoing regional nodal irradiation. Eligible breast ...
Eligibility Criteria
Inclusion
- Female;
- Older than 18;
- Breast cancer stage T1 - T3;
- At least 1 lymph node positive;
- Treated with mastectomy or conservative surgery;
- Negative surgical margins;
- No distant metastasis;
- No supraclavicular or internal mammary nodes metastases;
- Adjuvant systemic therapy with chemotherapy, endocrine therapy or anti-HER2 (Human - - Epidermal Growth Factor Receptor 2) treatment is accepted;
- Signed informed consent.
Exclusion
- Positive surgical margins;
- Concomitant chemotherapy;
- Supraclavicular or internal mammary nodes metastases;
- Distant metastasis;
- Previous thoracic radiotherapy;
- Bilateral breast cancer;
- Patients with collagen diseases;
- Unable or unwilling to sign inform consent.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04015531
Start Date
July 1 2019
End Date
December 1 2020
Last Update
July 11 2019
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