| Title |
A Randomized Trial of Five-Fraction Partial Breast Irradiation |
| Protocole ID |
RAPID2 |
| ClinicalTrials.gov ID |
NCT05417516 |
| Cancer Type(s) |
Breast |
| Phase |
|
| Stage |
|
| Study Type |
Clinical |
| Drug |
Radiothérapie |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 HOPITAL DE L'ENFANT-JESUS
1401 18e Rue, Québec, QC, G1J 1Z4
|
| City |
|
| Principal Investigator |
Dr. Valérie Théberge
|
| Coordinator |
Josée Allard
418-525-4444 poste 67296
|
| Status |
Recruiting |
| Activation Date |
18-10-2023 |
| Eligibility Criteria |
- Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease.(AJCC TNM Cancer Staging).
- Treated by BCS with microscopically clear resection margins ≥ 1mm for invasive and non-invasive disease or no residual disease on re-excision.
- Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection.
|
| Exclusion Criteria |
- Age less than 50 years.
- Known to be BRCA 1 and/or BRCA 2 positive.
- Tumour size >3cm in greatest diameter on pathological examination.
- Lobular carcinoma only.
- More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).
- Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible).
- History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma.
- Known pregnancy or currently lactating.
- Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma).
- Inability to plan the patient for the experimental technique.
|
| |
|
Groupe d'étude en oncologie du Québec