CCTG EN.11- RAINBO

Refining Adjuvant Treatment in Endometrial Cancer Based On Molecular Features

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Population: Gyne - Endometrial Cancer

Line of therapy: Adjuvant

Intervention: Participants of the four RAINBO trials should be eligible according to the inclusion and exclusion criteria of both the overarching RAINBO trials program and the clinical trial that they are assigned to based on the molecular profile.

Key Inclusion Criteria

1. Histologically confirmed diagnosis of endometrial cancer (EC) of the following histotypes: endometrioid endometrial carcinoma, serous endometrial carcinoma, uterine clear cell carcinoma, dedifferentiated and undifferentiated endometrial carcinoma, uterine carcinosarcoma and mixed endometrial carcinomas of the aforementioned histotypes.

2. Full molecular classification performed following the diagnostic algorithm described in WHO 2020 (5th Edition, IARC, Lyon, 2020)

3. Hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy or sentinel node biopsy, without macroscopic residual disease after surgery

4. No distant metastases as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan)

5. WHO performance status 0, 1 or 2

6. Expected start of adjuvant treatment (if applicable) within 10 weeks after surgery

7. Patients must be accessible for treatment and follow-up

8. Written informed consent for participation in one of the RAINBO trials, permission for the contribution of a tissue block for translation research and permission for the use and sharing of data for the overarching research project according to the local Ethics Committee requirements.

9. Eligible patients will be assigned to one of the four RAINBO trials based on the molecular profile of their cancer:

   - p53 abnormal endometrial cancer patients to the p53abn-RED trial

   - mismatch repair deficient endometrial cancer patients to the MMRd-GREEN trial

   - no specific molecular profile endometrial cancer patients to NSMP-ORANGE trial

   - POLE mutant endometrial cancer patients to the POLEmut-BLUE trial

   
   

Key Exclusion Criteria

1. History of another primary malignancy, except for non-melanoma skin cancer, in the past 5 years

2. Prior pelvic radiation

Sponsor: CCTG

CRP Contact:  martha.elbebawy@ladydavis.ca

514-340-8222 ext. 28224

CRP PI: Dr. S. Lau

Status: On hold