OncoMatch/Clinical Trials/NCT06712472
Randomized Phase III Trial Testing Maintenance Olaparib Versus Observation After Adjuvant Chemoradiation for p53abn Endometrial Cancer
Is NCT06712472 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Olaparib (300 mg BID) for endometrial cancer.
Treatment: Olaparib (300 mg BID) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Endometrial Cancer
Biomarker criteria
Required: TP53 abnormal
Molecular classification: p53abn EC*
Required: POLE wild-type
must be pMMR and POLE wildtype (or non-pathogenic) for inclusion
Required: MMR proficient
must be pMMR and POLE wildtype (or non-pathogenic) for inclusion
Disease stage
Required: Stage I, II, III
Excluded: Stage IV
Performance status
WHO 0–1
Prior therapy
Must have received: radiation therapy (pelvic external beam radiotherapy, vaginal brachytherapy) — adjuvant
Patient must receive or have received a sequential radiotherapy and chemotherapy preferably given according to the PORTEC-3 regimen and should be started within 6 to 8 weeks after surgery and no later than 10 weeks
Must have received: platinum-based chemotherapy (cisplatin, carboplatin, paclitaxel) — adjuvant
two cycles of intravenous cisplatin 50mg/m² in the first and fourth week of the pelvic external beam radiotherapy (EBRT) +/- vaginal brachytherapy followed by four cycles of intravenous carboplatin AUC 5 and paclitaxel 175 mg/m² at 21-day intervals. However the sequence of chemotherapy, number of cycles and inclusion of cisplatin may be altered according to local practice at the investigator's discretion.
Cannot have received: pelvic irradiation
Prior pelvic irradiation
Cannot have received: PARP inhibitor (olaparib)
Any previous treatment with a PARP inhibitor, including olaparib
Lab requirements
Blood counts
hemoglobin ≥10.0 g/dl with no blood transfusion in the past 28 days, ANC ≥1.5 x 10^9/l, platelet count ≥ 100 x 10^9/l
Kidney function
creatinine <1.5 ULN or creatinine clearance ≥ 51 mL/min
Liver function
bilirubin ≤1.5 x institutional ULN (except Gilbert's syndrome); ALT (SGPT) and/or AST (SGOT) ≤2.5 x ULN
Adequate systemic organ function: ... Creatinine clearance (> 50 cc/min): Patients must have creatinine less than 1.5 ULN or calculated creatinine clearance estimated of ≥ 51 mL/min ... hemoglobin ≥10.0 g/dl with no blood transfusion in the past 28 days, Absolute neutrophil count (ANC) ≥1.5 x 109/l, platelet count ≥ 100 x 109/l. ... bilirubin ≤1.5 x institutional upper limit of normal (ULN). ... ALT (SGPT) and/or AST (SGOT) ≤2.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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