Status:
UNKNOWN
Radiation Dose Intensity Study in Breast Cancer in Young Women
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
UNICANCER
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
hypothesis: 10 Gy additional boost to the tumor bed will yield an increase in local control at 10 years from 88% to 93%, with still acceptable cosmesis.
Detailed Description
Title of the study: Radiation dose intensity study in breast cancer in young women: a randomized phase III trial of additional dose to the tumor bed. Background and aim of the study: Several studie...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age 50 years or younger.
- Histological diagnosis of invasive mammary cancer including all subtypes of invasive adenocarcinoma.
- Tumor location and extension imaged prior to surgery using at least mammography and ultrasound.
- Unicentric tumors and multifocal tumors removed using a wide local excision; microscopic radical resection (focally involved margins allowed, defined as:
- any DCIS or invasive carcinoma in 3 or fewer low-power fields (using a x 4 objective and a x 10 ocular lens, which has a diameter of 5 mm per low-power microscopic fields).
- Sentinel lymph node biopsy and/or axillary lymph node dissection has been performed.
- Breast cancer stage: pT1-2pN0-2a M0.
- No treatment is allowed prior to surgery (no neoadjuvant chemotherapy, no neoadjuvant hormonal therapy, no pre-operative radiotherapy).
- In cases where no adjuvant chemotherapy is given, wide local excision has been performed \< 10 weeks before the start of radiotherapy.
- In cases where adjuvant chemotherapy is given immediately after surgery, wide local excision has been performed \< 6 months before the start of radiotherapy, and chemotherapy should be completed \< 6 weeks before the start of radiotherapy.
- In cases where hormonal treatment is planned, this is given after completion of the radiotherapy.
- No previous history or synchronous malignant tumor in the other breast, previous history of malignant disease, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- ECOG performance scale 2 or less.
- Exclusion criteria:
- Residual microcalcifications on mammogram.
- All histological types of malignancies other than invasive adenocarcinoma.
- In situ carcinoma of the breast, without invasive tumor.
- Concurrent pregnancy.
- Multicentric tumors, and multifocal. tumors excised using multiple excisions \* Invasive breast cancer in both breasts.
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
2400 Patients enrolled
Trial Details
Trial ID
NCT00212121
Start Date
July 1 2004
End Date
December 1 2025
Last Update
January 21 2022
Active Locations (18)
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1
Hôpital J-Minjoz
Besançon, France, 25030
2
Institut Bergonié
Bordeaux, France, 33076
3
CHU Henri Mondor
Créteil, France, 94000
4
Centre Oscar Lambret
Lille, France, 59000