Status:
COMPLETED
Pre- or Postoperative Accelerated Radiotherapy
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Kom Op Tegen Kanker
Conditions:
Breast Cancer
Radiation Toxicity
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
20 non-metastasized breast cancer patients receiving neoadjuvant chemotherapy will be randomized between preop or postop RT. Patients with clinically suspicious axillary lymph nodes will receive a fin...
Detailed Description
In early-stage breast cancer the cornerstone of treatment is surgery. There are 2 possibilities: either mastectomy (ME, the whole breast, including the tumour, is removed) or breast-conserving surgery...
Eligibility Criteria
Inclusion
- All of the following inclusion criteria must be met:
- female patients with non-metastatic breast cancer,
- biopsy proven,
- age ≥ 18 years,
- WHO performance status 0 or 1,
- using contraceptives if in reproductive age category
- eligible for neo-adjuvant CT after multidisciplinary decision,
- informed consent obtained, signed and dated before specific protocol procedures.
Exclusion
- Any one or combination of the following:
- distant metastases,
- inflammatory breast cancer (mastitis carcinomatosa),
- multifocal tumor,
- lobular carcinoma,
- bilateral breast cancer,
- history of cancer, with the exception of non-melanoma skin cancer, in situ cervix carcinoma
- history of chemotherapy,
- history of radiation treatment,
- pregnant or breast feeding, or not using contraceptives if in reproductive age category
- exclusion criteria for chemotherapy:
- leukocytes \< 2500
- absolute neutrophil count \< 1000/µL
- hemoglobine \< 8 g/dL (transfusion is allowed)
- platelets \< 100 000/µl
- total bilirubine \> 1.5 x maximal normal reference range
- AST \> 2.5 x maximal normal reference range
- ALT \> 2.5 x maximal normal reference range
- creatinine \> 1.5 x maximal normal reference range
- Left ventricular ejection fraction (LVEF) \< 55%
- planned immediate reconstructive surgery,
- conditions making toxicity evaluation difficult (e.g. skin disorders),
- Amiodarone treatment in the last 6 months
- patients unlikely to comply with the protocol (e.g. inability to return for follow-up visits or unlikely to complete the study).
Key Trial Info
Start Date :
September 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03783364
Start Date
September 17 2018
End Date
November 19 2021
Last Update
January 4 2023
Active Locations (2)
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1
Department of Radiotherapy, University Hospital Ghent
Ghent, Oost-Vlaanderen, Belgium, 9000
2
University Hospital Ghent
Ghent, Belgium, 9000