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Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features

ConditionEndometrial Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLeiden University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pelvic external beam radiotherapy

    Radiation

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

  • Chemotherapy

    Drug

    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.

  • Durvalumab

    Drug

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

  • Vaginal brachytherapy

    Radiation

    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).

Treatment groups

316 Participants
are divided into 2 treatment groups
Group A: MMRd-GREEN trial: experimentalExperimental treatment 3 interventions
Group B: MMRd-GREEN trial: controlActive comparator 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame
3 years

Secondary outcomes

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.

Time frame
5 years
2

Quality of Life Endpoints

Quality of life analysis using the EORTC QLQC30 and QLQEN24.

Time frame
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.

Time frame
3 years, 5 years
4

Biomarker

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

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Leiden University Medical Center

Lead sponsor

Dutch Gynaecological Oncology Group

Collaborator

Cancer Research UK & UCL Cancer Trials Centre

Collaborator

Dutch Cancer Society

Collaborator

AstraZeneca

Collaborator

National Cancer Institute, France

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

BGOG: Belgian Gynaelogical Onology Group, Belgium

Collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborator

Institute Gustave Roussy Paris

Collaborator

Central & Eastern European Gynecologic Oncology Group (CEEGOG)

Collaborator

Canadian Cancer Trials Group (CCTG)

Collaborator

Source ClinicalTrials.gov
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