The RAINBO program is a studies group which proposes personalized treatment of patients suffering from endometrial cancer according to their molecular profile.
the RAINBO-RED study allows observation or maintenance treatment with targeted therapy for one year (olaparib). This after standard therapy. The goal is to improve recurrence-free survival of patients treated with Olaparib.
Histologically confirmed diagnosis of EC (all grades and the following histologic subtypes : endometrioid, serous, clear cell, de-/undifferentiated carcinomas, and uterine carcinosarcoma).
Molecular classification performed following the diagnostic algorithm described in WHO 2020 (adapted from Vermij et al.)
TLH-BSO or TAH-BSO with or without lymphadenectomy or sentinel node biopsy, without macroscopic residual disease after surgery
No distant metastases as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or PET-CT scan)
FIGO Stage IV disease of any histology even if there is no evidence of disease after surgery
Prior pelvic irradiation
Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.
Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.
Parallel
Olaparib (300 mg BID)
DrugOlaparib 300mg Bid during one year.
Recurrence-Free survival
To assess whether maintenance therapy with olaparib improves recurrence-free survival (RFS), as compared to observation after chemo-radiotherapy in patients with p53abn HREC
Click on the lead sponsor to view all of their trials.
Gustave Roussy, Cancer Campus, Grand Paris
Lead sponsor
AstraZeneca
Collaborator
