Randomized Phase III Trial Testing Maintenance Olaparib Versus Observation After Adjuvant Chemoradiation for P53abn Endometrial Cancer

Phase 3

Recruiting

• Conditions: Endometrial Cancer; P53abn
• Interventions: Drug: Olaparib (300 mg BID)

• Registration Number: NCT06712472
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-26
• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02
• Primary Completion: 2030-06
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 554

Inclusion Criteria

Not provided

Exclusion Criteria

• 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. Patients with a history of localised triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.
• FIGO Stage IV disease of any histology even if there is no evidence of disease after surgery
• Prior pelvic irradiation
• 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.
• Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
• Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
• Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
• Major surgical procedure (as defined by the Investigator) within 2 weeks prior randomization and patients must have recovered from any effects of any major surgery.
• History of allogenic organ transplantation.
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
• Patient with severe hepatic impairment
• Any previous treatment with a PARP inhibitor, including olaparib.
• History of active primary immunodeficiency
• History or evidence of hemorrhagic disorders within 6 months prior to randomization
• Patients with myelodysplastic syndrome/acute myeloid leukemia history or with features suggestive of MDS/AML.
• Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
• Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immuno-deficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
• Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
• Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
• Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
• Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
• Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
• Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
• Treatment with an unlicensed or investigational product within 4 weeks of trial entry.
• Pregnant and breastfeeding patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm	Olaparib (300 mg BID)	-

Primary Outcome Measures

Name	Time	Method
Recurrence-Free survival	3 years	To assess whether maintenance therapy with olaparib improves recurrence-free survival (RFS), as compared to observation after chemo-radiotherapy in patients with p53abn HREC

Trial Locations

Locations (15)

Centre Hospitalier D'Albi; 🇫🇷 Albi, France

Centre Hospitalier de Carcassonne; 🇫🇷 Carcassonne, France

Chu Dijon; 🇫🇷 Dijon, France

Groupe Hospitalier Mutualiste de Grenoble; 🇫🇷 Grenoble, France

Institut Cancerologie de L'Ouest-Angers; 🇫🇷 Angers, France

CHU De LIMOGES; 🇫🇷 Limoges, France

Centre LEON BERARD; 🇫🇷 Lyon, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

Chu Besancon; 🇫🇷 Besancon, France

Centre Antoine LACASSAGNE; 🇫🇷 Nice, France

Institut Marie-Curie; 🇫🇷 Paris, France

Hopital Cochin; 🇫🇷 Paris, France

INSTITUT CANCEROLOGIE DE L'OUEST-St HERBLAIN; 🇫🇷 st - HERBLAIN, France

Clinique Sainte Anne; 🇫🇷 Strasbourg, France

Gustave Roussy; 🇫🇷 Villejuif, France