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Endometrial CancerPhase 3RAINBO-REDNCT06712472

Randomized Phase III Trial Testing Maintenance Olaparib Versus Observation After Adjuvant Chemoradiation for p53abn Endometrial Cancer

A Phase 3 study testing Olaparib (300 mg BID) in people with Endometrial Cancer and p53abn, run by Gustave Roussy, Cancer Campus, Grand Paris at 15 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer, p53abn
What is being tested?
Olaparib (300 mg BID)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
554 participants
Where
15 sitesFrance
Study dates
26 Jun 2024to Dec 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • Written informed consent prior to any study specific procedures
  • Age >= 18 years
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  • Patients must have a life expectancy ≥ 16 weeks
  • Patients must be accessible for treatment and follow-up
  • Written informed consent for one of the RAINBO trials and the overarching research project according to the local Ethics Committee requirements.
  • WHO Performance score 0-1
  • Histologically confirmed Stage I to III EC with myometrial invasion
  • Molecular classification: p53abn EC*
  • Body weight > 30 kg
  • 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: 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.
  • This may include;
  • 4 cycles carboplatin \& paclitaxel before or after radiotherapy with 2 cycles cisplatin
  • 4 cycles carboplatin \& paclitaxel before or after radiotherapy (no cisplatin)
  • 6 cycles carboplatin \& paclitaxel before or after radiotherapy (no cisplatin)
  • Patients registered after their standard treatment must:
  • provide a tumor assessment performed within the 4 weeks before the start of RT/CT. This will be considered as the M0.
  • have started RT/CT 6 to 8 weeks after surgery. A maximum gap of 10 weeks is accepted.
  • be randomized within two weeks before maintenance or observation.
  • Adequate systemic organ function: Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
  • Creatinine clearance (> 50 cc/min): Patients must have creatinine less than 1.5 ULN or calculated creatinine clearance estimated of ≥ 51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test. Estimated creatinine clearance = (140-age [years]) x weight (kg) (x F) / serum creatinine (mg/dL) x 72
  • Adequate bone marrow function : 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.
  • Adequate liver function: bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
  • ALT (SGPT) and/or AST (SGOT) ≤2.5 x ULN
  • *Molecular classification must be performed according to the diagnostic algorithm presented in the WHO 2020 (Vermij et al. 2020). For the p53abn-RED trial this means that MMR and POLE status must be determined, and must be pMMR and POLE wildtype (or non-pathogenic) for inclusion. For details on the molecular classification see 7.1: Diagnostic algorithm for molecular classification.
  • Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
  • Patients must be affiliated to a social security system or beneficiary of the same

Who cannot join

  • 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.
  • 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).
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  • Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
  • 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.
  • Significant traumatic injury within 4 weeks of the first dose of olaparib.
  • 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.
  • Breastfeeding patients

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alexandra Leary, MD, PhD contact

+33 1 42 11 42 11

Alexandra.LEARY@gustaveroussy.fr

Flora NGADJEUA TCHOUATIEU, PhD contact

+33 1 42 11 42 11

Flora.NGADJEUA-TCHOUATIEU@gustaveroussy.fr

15 sites in 1 country

France15 sites, 15 recruiting

  • Centre Hospitalier D'Albi

    Albi, 81000

    Aurelie ASSEMAT, MD, +33 5 63 47 47 47, aurelie.assemat@ch-albi.fr

    Recruiting

  • Institut Cancerologie de L'Ouest-Angers

    Angers, 49055

    Paule AUGEREAU, MD, +33 2 41 35 27 00, paule.augereau@ico.unicancer.fr

    Recruiting

  • Chu Besancon

    Besançon, 25030

    Laura MANSI, MD, +33 3 81 66 81 66, lmansi@chu-besancon.fr

    Recruiting

  • Centre Hospitalier de Carcassonne

    Carcassonne, 11000

    Jean-Luc LABOUREY, MD, +33 4 68 24 24 24, jean-luc.labourey@ch-carcassonne.fr

    Recruiting

  • Chu Dijon

    Dijon, 21000

    Marie CHAIX, MD, +33 3 80 29 30 31, marie.chaix@chu-dijon.fr

    Recruiting

  • Groupe Hospitalier Mutualiste de Grenoble

    Grenoble, 38000

    Elise BONNET, MD, +33 4 76 70 70 00, elise.bonnet@avec.fr

    Not yet recruiting

  • CHU De LIMOGES

    Limoges, 87000

    Elise DELUCHE, MD, +33 5 55 05 55 55, elise.deluche@chu-limoges.fr

    Recruiting

  • Centre LEON BERARD

    Lyon, 69008

    Isabelle RAY-COQUARD, MD, +33 4 78 78 28 28, isabelle.ray-coquard@lyon.unicancer.fr

    Recruiting

  • Institut Paoli Calmettes

    Marseille, 13009

    Renaud SABATIER, MD, +33 4 91 22 33 33, sabatierr@ipc.unicancer.fr

    Recruiting

  • Centre Antoine LACASSAGNE

    Nice, 06189

    Philippe Follana, MD, +33 4 92 03 10 00, philippe.follana@nice.unicancer.fr

    Recruiting

  • Institut Marie-Curie

    Paris, 75005

    Audrey BELLESOEUR, MD, +33 1 56 24 55 00, audrey.bellesoeur@curie.fr

    Recruiting

  • Hopital Cochin

    Paris, 75014

    Jerome ALEXANDRE, MD, +33 1 58 41 41 41, jerome.alexandre@aphp.fr

    Not yet recruiting

  • INSTITUT CANCEROLOGIE DE L'OUEST-St HERBLAIN

    Saint-Herblain, 44800

    Jean-Sebastien FRENEL, MD, +33 2 40 67 99 00, jean-sebastien.frenel@ico.unicancer.fr

    Recruiting

  • Clinique Sainte Anne

    Strasbourg, 67000

    YOUCEF TAZI, MD, +33 3 88 45 81 81, ytazi@solcrr.org

    Recruiting

  • Gustave Roussy

    Villejuif, 94805

    Alexandra Leary, MD PhD, +33 1 42 11 42 11, alexandra.leary@gustaveroussy.fr

    Recruiting

Other trials in France

About this study

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.

Being tested
Olaparib (300 mg BID)
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Olaparib (300 mg BID)Drug

    Olaparib 300mg Bid during one year.

Study groups in NCT06712472
Study groupRoleWhat they receive
Standard armNo interventionNot described
Experimental armExperimentalNot described
Receives: Drug: Olaparib (300 mg BID)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2024
  2. Study start26 Jun 2024
  3. Primary completionJun 2030 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
554 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06712472
Sponsor's protocol ID
2023-503886-44-00
Other IDs
2023/3603, 2023
Acronym
RAINBO-RED
Status last verified
Jan 2026
First submitted
26 Nov 2024
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olaparib (300 mg BID) in people with Endometrial Cancer and p53abn, run by Gustave Roussy, Cancer Campus, Grand Paris at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexandra Leary, MD, PhD (+33 1 42 11 42 11, Alexandra.LEARY@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-Free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06712472.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

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RAINBO-RED Clinical Trial NCT06712472 | AzTrials