Status:
RECRUITING
Clinical Database of Safe Personalized Adjuvant Breast Radiotherapy Based on Individual Radiosensitivity
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Breast Cancer
Eligibility:
FEMALE
65+ years
Brief Summary
Severe but also moderate toxicities after curative-intent radiotherapy (RT), such as a poor cosmetic outcome following breast cancer can have a negative impact on quality of life and a marked effect o...
Detailed Description
Severe but also moderate toxicities after curative-intent radiotherapy (RT), such as a poor cosmetic outcome following breast cancer can have a negative impact on quality of life and a marked effect o...
Eligibility Criteria
Inclusion
- Compliant women ≥ 65 years old.
- Conservative breast cancer surgery.
- T1-T2; N sentinel negative/N0.
- Luminal A tumors.
- Tumor negative margins.
- Indication of whole breast irradiation only.
- Extension evaluation of disease will be proven negative (M0).
- Must be geographically accessible for follow-up.
- Written and dated informed consent.
- Affiliated to the French social security system.
Exclusion
- Patients with distant metastases.
- Indications of node irradiation.
- Synchronous bilateral breast cancer.
- Patients treated by radical mastectomy.
- Patients with neoadjuvant therapy.
- Patients with previous or concomitant other (not breast cancer) malignancy within the past 3 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least three years.
- Patients with other unstable or untreated non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.
- Patients treated with systemic investigational drugs within the past 30 days
Key Trial Info
Start Date :
May 23 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04282122
Start Date
May 23 2019
End Date
June 1 2026
Last Update
February 12 2025
Active Locations (1)
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1
Institut Régional du Cancer de Montpellier
Montpellier, Occ, France, 34298