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 (Jun 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
Treatments studied
Other
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
Demographics
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.
Frequently asked questions
Is NCT06712472 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior pelvic irradiation, PARP inhibitor disqualifies patients from enrollment.
Does this trial require TP53?
Yes, TP53 abnormal is a required biomarker for enrollment.
Does this trial require POLE?
Yes, POLE wild-type is a required biomarker for enrollment.
Does this trial require MMR?
Yes, MMR proficient is a required biomarker for enrollment.
What disease stage is eligible?
Stage I or II or III is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages