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Endometrial CancerPhase 3RAINBO-GREENNCT05255653

Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features

A Phase 3 study testing Pelvic external beam radiotherapy, Chemotherapy and Durvalumab in people with Endometrial Cancer, run by Leiden University Medical Center at 60 sites in 7 countries.

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

RAINBO MMRd-GREEN is an international, multicenter, phase III randomised trial wherein adjuvant pelvic external beam radiotherapy combined with and followed by durvalumab for one year is compared to adjuvant pelvic external beam radiotherapy with or without chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Pelvic external beam radiotherapy, Chemotherapy and Durvalumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
316 participants
Where
60 sitesin 7 countries
Study dates
11 Nov 2021to 1 Jan 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 endometrial cancer (EC) of the following histotypes: endometrioid endometrial carcinoma, serous endometrial carcinoma, uterine clear cell carcinoma, dedifferentiated and undifferentiated endometrial carcinoma, uterine carcinosarcoma and mixed endometrial carcinomas of the aforementioned histotypes.
  • Full molecular classification performed following the diagnostic algorithm described in WHO 2020 (5th Edition, IARC, Lyon, 2020)
  • 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/MRI scan of chest, abdomen and pelvis or PET-CT scan)
  • Age ≥ 18 years
  • Expected start of adjuvant treatment (if applicable) within 10 weeks after surgery
Show all 19Show fewer
  • Patients must be accessible for treatment and follow-up
  • Written informed consent for participation in one of the RAINBO trials, permission for the contribution of a tissue block for translation research and permission for the use and sharing of data for the overarching research project according to the local Ethics Committee requirements.
  • Written informed consent
  • WHO Performance score 0-1
  • Histologically confirmed FIGO 2009 stage IB/II with LVSI, stage III, or stage IV with limited pelvic peritoneal involvement (FIGO 2023 stage IB with LVSI, stage II with myometrial or cervical stroma involvement and LVSI, or stage III disease)
  • Molecular classification: MMRd EC*
  • No prior pelvic radiotherapy
  • Body weight > 30 kg
  • Adequate systemic organ function:
  • Creatinine clearance (> 40 cc/min): Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.
  • Adequate bone marrow function : hemoglobin >9.0 g/dl, Absolute neutrophil count (ANC) ≥1.0 x 109/l, platelet count ≥75 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

Who cannot join

  • History of another primary malignancy, except for non-melanoma skin cancer, in the past 5 years
  • Prior pelvic radiation
  • The MMRd-GREEN trial
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of Investigational medicinal product (IMP).
  • 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.
Show all 20Show fewer
  • Any previous treatment with a PD(L)1 inhibitor, including durvalumab.
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IMP.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab with the exceptions of :
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection).
  • Systemic corticosteroids at physiologic doses not to exceed <<10 mg/day>> of prednisone or its equivalent.
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
  • History of active primary immunodeficiency
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome. The following are exceptions to this criterion:
  • Patients with vitiligo or alopecia
  • Patients with hypothyroidism (e.g., following Hashimoto syndrome)stable on hormone replacement
  • Any chronic skin condition that does not require systemic therapy
  • Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
  • 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.
  • 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.

Trial locations and contacts

60 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Elma Meershoek- Klein Kranenbarg contact

0031 71 526 3500

ClinicalResearchCenter@lumc.nl

Annet Roodvoets contact

ClinicalResearchCenter@lumc.nl

60 sites in 7 countries

Canada15 sites, 15 recruiting

  • Juravinski Cancer Center

    Hamilton

    Nidhi Kumar-Tyagi, kumarn@hhsc.ca;nguyenjmv@hhsc.ca

    Recruiting

  • BCCA Kelowna

    Kelowna

    Flavia De Angelis, flavia.deangelis@bccancer.bc.ca

    Recruiting

  • Kingston Health Sciences Centre

    Kingston

    Rania Chehade, rania.chehade@kingstonhsc.ca

    Recruiting

  • London Regional Cancer Centre

    London

    Stephen Welch, stephen.welch@lhsc.on.ca

    Recruiting

  • Centre Hospitalier de Universite de Montreal

    Montreal

    Vanessa Samouelian, vanessa.samouelian.med@ssss.gouv.qc.ca

    Recruiting

  • Jewish General Hospital

    Montreal

    Susie Lau, susie.lau@mcgill.ca

    Recruiting

  • Maisonneuve-Rosemont Hospital

    Montreal

    Suzanne Fortin, suzanne.fortin.med@ssss.gouv.qc.ca

    Recruiting

  • Allan Blair Cancer Centre

    Regina

    Maryam AlHayki, maryalhayki@gmail.com

    Recruiting

  • Saint John Regional Center

    Saint John

    Marissa Sherwood, marissa.sherwood@horizonnb.ca

    Recruiting

  • Saskatoon Cancer Centre

    Saskatoon

    Jennifer Brownbroderick, jennifer.BrownBroderick@saskcancer.ca

    Recruiting

  • Centre hospitalier universitaire de Sherbrooke

    Sherbrooke

    Mathieu Viau, mathieu.viau@usherbrooke.ca

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto

    Kathy Han, MD PhD, Kathy.Han@rmp.uhn.ca

    Recruiting

  • Sunnybrook Health Science Centre

    Toronto

    Eric Leung, eric.leung@sunnybrook.ca

    Recruiting

  • BC Cancer Vancouver

    Vancouver

    Corinne Mauricedror, corinne.mauricedror@bccancer.bc.ca

    Recruiting

  • BCCA Victoria

    Victoria

    Richard Gagnon, richard.gagnon@bccancer.bc.ca

    Recruiting

Other trials in Canada

Netherlands13 sites, 13 recruiting

  • Amsterdam University Medical Center

    Amsterdam

    Jacqueline Tromp, j.m.tromp@amsterdamumc.nl

    Jasper LA Vleugels, MD PhD

    Recruiting

  • Amphia Ziekenhuis

    Breda

    Joan Heijns, MD PhD, jheijns@amphia.nl

    Recruiting

  • Instituut Verbeeten

    Breda

    Frederieke Koppe, koppe.f@bvi.nl

    Recruiting

  • Catharina Ziekenhuis

    Eindhoven

    Annemarie Thijs, MD PhD, annemarie.thijs@catharinaziekenhuis.nl

    Recruiting

  • Medisch Spectrum Twente

    Enschede

    Machteld Wymenga, MD PhD, a.wymenga@mst.nl

    Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen

    Ann KL Reyners, MD PhD, a.k.l.reyners@umcg.nl

    Recruiting

  • MCL

    Leeuwarden

    Marco Polée, MD PhD, m.polee@mcl.nl

    Recruiting

  • RIF

    Leeuwarden

    Marianne de Jong, m.a.a.jong@skf-rif.nl

    Recruiting

  • Leiden University Medical Center

    Leiden, 2333ZA

    Judith R Kroep, MD PhD, +31 71 526 5095, j.r.kroep@lumc.nl

    Recruiting

  • Maastro

    Maastricht

    Nienke Kuijsters, nienke.kuijsters@maastro.nl

    Recruiting

  • MUMC

    Maastricht

    Tonneke Beijers, MD PhD, tonneke.beijers@mumc.nl

    Recruiting

  • Erasmus Medical Center

    Rotterdam

    Ingrid Boere, Md PhD, i.boere@erasmusmc.nl

    Recruiting

  • UMCU

    Utrecht

    Inge Baas, MD PhD, I.O.Baas-3@umcutrecht.nl

    Recruiting

Other trials in Netherlands

Germany11 sites, 11 recruiting

  • Evangelisches Waldkrankenhaus Spandau Berlin

    Berlin

    Katharina Carrizo, katharina.carrizo@jsd.de

    Recruiting

  • Klinikum Lippe

    Detmold

    Beyhan Ataseven, beyhan.ataseven@klinikum-lippe.de

    Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

    Barbara Schmalfeldt, b.schmalfeldt@uke.de

    Recruiting

  • Universitätsklinikum Heidelberg

    Heidelberg

    Thomas Deutsch, Thomas.Deutsch@umm.de

    Recruiting

  • Klinikum Kempten

    Kempten

    Ricardo Felberbaum, ricardo.felberbaum@klinikverbund-allgaeu.de

    Recruiting

  • Ludwigsburg

    Ludwigsburg

    Claudia Haenle, claudia.haenle@rkh-gesundheit.de

    Recruiting

  • Rotkreuzklinikum München

    München

    Moritz Hamann, moritz.hamann@swmbrk.de

    Recruiting

  • Diakoneo Diakonie-Klinikum Schwäbisch Hall

    Schwäbisch Hall

    Stefan Kommoss, stefan.kommoss@diak-klinikum.de

    Recruiting

  • Universitätsklinik Tübingen

    Tübingen

    Tobias Engler, tobias.engler@med.uni-tuebingen.de

    Recruiting

  • Universitätsklinikum Ulm

    Ulm

    Sabine Heublein, sabine.heublein@uniklinik-ulm.de

    Recruiting

  • Klinikum Worms

    Worms

    Matthias Koegel, matthias.koegel@klinikum-worms.de

    Recruiting

Other trials in Germany

France10 sites, 10 recruiting

  • CHU Jean Minjoz

    Besançon

    Laura Mansi, lmansi@chu-besancon.fr

    Recruiting

  • Institut Bergonie

    Bordeaux

    Coriolan LeBreton, c.lebreton@bordeaux.unicancer.fr

    Recruiting

  • Institut Leon Berard

    Lyon

    Olivia le Saux, olivia.lesaux@lyon.unicancer.fr

    Recruiting

  • Institut Paoli Calmattes-Marseille

    Marseille

    Renaud Sabatier, SABATIERR@ipc.unicancer.fr

    Recruiting

  • Institut du cancer de Montpellier

    Montpellier

    Stanislas Quesada, stanislas.quesada@icm.unicancer.fr

    Recruiting

  • Centre Antoine Lacassagne

    Nice

    Philippe Follana, philippe.follana@nice.unicancer.fr

    Recruiting

  • ICO Saint Herblain

    Saint-Herblain

    Jean-Sebastien Frenel, Jean-Sebastien.Frenel@ico.unicancer.fr

    Recruiting

  • Clinique Sainte-Anna

    Strasbourg

    Youssef Tazi, ytazi@solcrr.org

    Recruiting

  • Institut Universitaire de Cancer de Toulouse

    Toulouse

    Laurence Gladieff, gladieff.laurence@iuct-oncopole.fr

    Recruiting

  • Institute Gustave Roussy

    Villejuif

    Alexandra Leary, MD PhD, alexandra.LEARY@gustaveroussy.fr

    Recruiting

Other trials in France

Belgium6 sites, 6 recruiting

  • Antwerp University Hospital

    Antwerp

    Laure-Anne Teuwen, laure-anne.teuwen@uza.be

    Recruiting

  • Clinique Universitaire Saint-Luc

    Brussels

    Jean-Francois Baurain, jean-francois.baurain@saintluc.uclouvain.be

    Recruiting

  • GHDC

    Charleroi

    Sarah Lefèvre, sarah.lefevre@ghdc.be

    Recruiting

  • CHU Helora

    Mons

    Nathalie Cornez, nathalie.cornez@helora.be

    Recruiting

  • CHU UCL Namur

    Namur

    Stéphanie Henry, stephanie.henry@chuuclnamur.uc

    Recruiting

  • AZ Damiaan

    Ostend

    Isabelle Spoormans, isabelle.spoormans@azoostende.be

    Recruiting

Other trials in Belgium

Czechia4 sites, 4 recruiting

  • Fakultní nemocnice Hradec Králové

    Hradec Králové

    Ivan Praznovec, ivan.praznovec@fnhk.cz

    Recruiting

  • FN Bulovka

    Prague

    Michal Zikan, michal.zikan@bulovka.cz

    Recruiting

  • FN Motol

    Prague

    Anna Nohejlova, anna.nohejlova@fnmotol.cz

    Recruiting

  • Všeobecná fakultní nemocnice v Praze

    Prague

    Roman Kocian, roman.kocian@vfn.cz

    Recruiting

Other trials in Czechia

Italy1 site, 1 recruiting

  • Policlinico Universitario Fondazione Agostino Gemelli

    Roma

    Francesco Fanfani, francesco.fanfani@policlinicogemelli.it

    Recruiting

Other trials in Italy

About this study

Official title: RAINBO: Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features, TransPORTEC Platform Trials - MMRd-GREEN.

RAINBO MMRd-GREEN is an international, multicenter, phase III randomised trial wherein adjuvant pelvic external beam radiotherapy combined with and followed by durvalumab for one year is compared to adjuvant pelvic external beam radiotherapy with or without chemotherapy.

Read the detailed description

The MMRd-GREEN trial (NCT05255653) is an international, multicenter, phase III randomised trial wherein adjuvant pelvic external beam radiotherapy combined with and followed by durvalumab for one year is compared to adjuvant pelvic external beam radiotherapy with or without chemotherapy.

There are three other RAINBO trials, which are registered separately:

The p53abn-RED trial (NCT06712472) is an international, multicenter, phase III randomised trial wherein patients with completely resected invasive stage I-III p5abn endometrial cancer and treated with adjuvant chemoradiation will be randomized between olaparib for one year and observation.

The NSMP-ORANGE trial (NCT07831902) is an international, multicenter, non-inferiority phase III randomised trial wherein patients with stage II (with substantial LVSI) or stage III no-specific molecular profile (NSMP) endometrial cancer are randomised between standard chemoradiation and external beam radiotherapy followed by oral progestin for two years.

The POLEmut-BLUE trial (NCT05640999) is an international, multicenter, single arm, phase II trial wherein safety of de-escalation of adjuvant therapy in POLE-mutated endometrial cancer is investigated.

The overarching RAINBO research project will combine the data and tumor material of the four RAINBO clinical trials to perform translational research and compare molecular profile-based adjuvant therapy to standard adjuvant therapy in terms of effectiveness, toxicity, quality of life and cost utility.

Being tested
Pelvic external beam radiotherapy, Chemotherapy, Durvalumab, Vaginal brachytherapy
Keywords
Endometrial Cancer, Molecular risk factors, Durvalumab, Chemotherapy, Radiotherapy, MMRd
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • Pelvic external beam radiotherapyRadiation

    Also called EBRT

    45.0-48.6 Gy; 1.8-2.0 Gy per fraction, 5 fractions a week

  • ChemotherapyDrug

    Also called Cisplatin, Carboplatin, Paclitaxel

    Preferably concurrent and adjuvant according to the PORTEC-3 schedule: two cycles of intravenous cisplatin 50mg/m² in the first and fourth week of the pelvic external beam radiotherapy followed by four cycles of intravenous carboplatin AUC 5 and paclitaxel 175 mg/m² at 21-day intervals.

  • DurvalumabDrug

    Also called Imfinzi

    1500 mg intravenous once every 4 weeks for in total 1 year (13 cycles) starting within the first week of radiotherapy,

  • Vaginal brachytherapyRadiation

    Vaginal brachytherapy is to be considered in patients with documented cervical stromal involvement and/or substantial LVSI. Brachytherapy is given with a vaginal cylinder or vaginal ovoids or ring applicator, according to the center's standard technique. When using a cylinder, the active length will ideally be 2-3 cm, with the reference isodose covering the proximal 2.5-3 cm of the vagina. High-dose-rate (HDR) and pulse-dose-rate (PDR) schedules are permitted, which deliver an EQD2 equivalent dose of 10-14 Gy at 5 mm from the vaginal mucosa (to obtain a cumulative EDQ2 of 60 Gy at 5 mm).

Study groups in NCT05255653
Study groupRoleWhat they receive
MMRd-GREEN trial: experimentalExperimentalAdjuvant radiotherapy combined with and followed by durvalumab, 1500 mg intravenous once every 4 weeks for in total 1 year (13 cycles)
Receives: Radiation: Pelvic external beam radiotherapy; Drug: Durvalumab; Radiation: Vaginal brachytherapy
MMRd-GREEN trial: controlActive comparatorAdjuvant pelvic external beam radiotherapy +/- chemotherapy
Receives: Radiation: Pelvic external beam radiotherapy; Drug: Chemotherapy; Radiation: Vaginal brachytherapy

What is being measured

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

  1. Recurrence-free survival

    RFS is defined as time from randomization until date of any recurrence (local or distant) or date of death due to any cause.

    Measured: 3 years

Secondary outcomes (5)

  1. Efficacy endpoints

    • Investigator assessed median and 5-year RFS
    • Vaginal RFS, pelvic RFS, distant metastasis free-survival (median, 3-year, 5-year)
    • Disease-specific survival (median, 3-year, 5-year)
    • Overall Survival (OS) (median, 3 year, 5 year): will be determined from the date of randomization to the date of death from any cause. Subjects who have not died at the time of data freeze for the final analysis will be censored at the date the patient was last known to be alive.

    Measured: 5 years

  2. Quality of Life Endpoints

    Quality of life analysis using the EORTC QLQC30 and QLQEN24.

    Measured: 5 years

  3. Safety and tolerability endpoints.

    Safety and tolerability endpoints will consist of the evaluation of side-effects according to the NCI-CTCAE version 5, AEs, withdrawals due to AEs, dose interruptions.

    Measured: 3 years, 5 years

  4. Biomarker

    PD-L1 expression assessment using the SP263 immunohistochemistry assay (thresholds: ≥1% and ≥5%)

    Measured: Baseline

  5. Exploratory translational research

    Exploratory translational research:

    • MMRd-GREEN specific:
    • Evaluation of antigen presentation status (e.g. JAK1/2 and B2M mutational status)

    Measured: 3 years, 5 years

Timeline

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

  1. First posted24 Feb 2022
  2. Study start11 Nov 2021
  3. Primary completion1 Jan 2030 (estimated)
  4. Study completion1 Jan 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
Model description
Platform trial wherein eligible patients are assigned to one of four parallel running clinical trials. Here, the MMRd-GREEN trial is registered. The MMRd GREEN trial has a superiority design.
Masking
None (open label)
Enrolment
316 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05255653
Sponsor's protocol ID
RAINBO-GREEN
Other IDs
ENGOT-en14
Acronym
RAINBO-GREEN
Status last verified
Oct 2026
First submitted
1 Feb 2022
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Following the planned translational work in the RAINBO programme and publications, the translational research (TR) committee will open up the sample collection to external researchers. Access will be granted following completion of a research proposal form and approval by the TR committee chaired by Dr. Tjalling Bosse. All external researchers will be expected to demonstrate funding for their project and ethics approval. Data will be made available as required through data sharing agreements. The following will be reviewed when considering applications for data sharing and sample access: data and sample use is in-keeping with patient consent, the proposed project has scientific value, with defined objectives and study plan, trial data are appropriate for the intended purpose, acknowledgement of the RAINBO Programme in all publications that arise from the data sharing, compliance with legal and regulatory requirements as applicable and patient confidentiality maintained at all times.

Publications

  • IMPLEMENTATION OF COLLABORATIVE TRANSLATIONAL RESEARCH (TRANSPORTEC) FINDINGS IN AN INTERNATIONAL ENDOMETRIAL CANCER CLINICAL TRIALS PROGRAM (RAINBO). T Bosse, M Powell, E Crosbie, A Leary, J Kroep, K Han, J Mcalpine, N Horeweg, S De Boer, M De Bruyn, R Nout, V Smit, HW Nijman, N Singh, H Mackay, R Edmondson, L Mileshkin, D Church, H Kitchener, CL Creutzberg. Int J Gynecol Cancer 2021;31(Suppl 3):A1-A395. DOI: 10.1136/ijgc-2021-ESGO.171

  • RAINBO Research Consortium. Refining adjuvant treatment in endometrial cancer based on molecular features: the RAINBO clinical trial program. Int J Gynecol Cancer. 2023 Jan 3;33(1):109-117. doi: 10.1136/ijgc-2022-004039.

    PubMed 36600534

  • Secord AA, Powell MA, McAlpine J. Molecular Characterization and Clinical Implications of Endometrial Cancer. Obstet Gynecol. 2025 Nov 1;146(5):660-671. doi: 10.1097/AOG.0000000000006080. Epub 2025 Sep 18.

    PubMed 40966692

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pelvic external beam radiotherapy, Chemotherapy and Durvalumab in people with Endometrial Cancer, run by Leiden University Medical Center at 60 sites in 7 countries.

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 19 inclusion and 20 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Canada, Netherlands, Germany, France, Belgium and 2 more countries. 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 Elma Meershoek- Klein Kranenbarg (0031 71 526 3500, ClinicalResearchCenter@lumc.nl), 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 NCT05255653, which also lists 3 linked publications.

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 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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