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Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features

Study acronym: RAINBO-GREEN
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints removed 4 → 1 primary endpoints
Enrollment reduced 80% 1615 → 316 participants
See other at-risk trials from Leiden University Medical Center

Record History

  1. Primary endpoint(s) modified Enrollment reduced: 1615 → 316 participants · Phase changed: Phase 2/3 → Phase 3 · Trial sites expanded: 14 → 60 locations · 7 more Show 10 more changesShow less
    • Enrollment reduced: 1615 → 316 participants
    • Phase changed: Phase 2/3 → Phase 3
    • Trial sites expanded: 14 → 60 locations
    • Interventions modified
    • Trial arms changed: 8 → 2
    • Eligibility criteria shortened, about 861 words
    • Secondary endpoints: 8 to 5
    • Study description expanded, about 22 words
    • Collaborators revised (11)
    • Publications: details revised at 3 of 3 entries
  2. Re-verified, no change to tracked fieldsv9
  3. Eligibility criteria shortened, about 37 words Site contacts updated at 1 of 14 sites · Publications: details revised at 2 of 3 entries · Study description expanded, about 4 wordsv8 Show 3 more changesShow less
    • Site contacts updated at 1 of 14 sites
    • Publications: details revised at 2 of 3 entries
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 6 to 14 Study description expanded, about 4 wordsv7 Show 1 more changeShow less
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: 1611 to 1615 Interventions: Chemotherapy (Drug), Durvalumab (Drug), Medroxyprogesterone Acetate (Drug), Megestrol Acetate (Drug), Observation (Other), Olaparib (Drug)… to Chemotherapy (Drug), Durvalumab (Drug), Medroxyprogesterone Acetate (Drug), Megestrol Acetate (Drug), Observation (Other), Olaparib (Drug)… · Eligibility criteria expanded, about 264 words · Collaborators: 9 to 11 · 2 morev6 Show 5 more changesShow less
    • Interventions: Chemotherapy (Drug), Durvalumab (Drug), Medroxyprogesterone Acetate (Drug), Megestrol Acetate (Drug), Observation (Other), Olaparib (Drug)… to Chemotherapy (Drug), Durvalumab (Drug), Medroxyprogesterone Acetate (Drug), Megestrol Acetate (Drug), Observation (Other), Olaparib (Drug)…
    • Eligibility criteria expanded, about 264 words
    • Collaborators: 9 to 11
    • Publications: details revised at 1 of 3 entries
    • Study arms: 7 to 8

    See this version in full on ClinicalTrials.gov ↗

Show 4 earlier versionsHide 4 earlier versions
  1. Eligibility criteria shortened, about 2 wordsv5 See this version in full on ClinicalTrials.gov ↗
  2. Start date: Jun 10, 2022 to Nov 11, 2021v4
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 1, 2022 to Jun 10, 2022 · Site details revised at 6 of 6 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of May 1, 2022 to Jun 10, 2022
    • Site details revised at 6 of 6 sites
  4. Start date: Feb 15, 2022 to May 1, 2022 Collaborators: 7 to 9v2 Show 1 more changeShow less
    • Collaborators: 7 to 9

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05255653
Lead Sponsor Leiden University Medical Center
Collaborators: Dutch Gynaecological Oncology Group, Cancer Research UK & UCL Cancer Trials Centre, Dutch Cancer Society, AstraZeneca, National Cancer Institute, France, Canadian Institutes of Health Research (CIHR), BGOG: Belgian Gynaelogical Onology Group, Belgium, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Institute Gustave Roussy Paris, Central & Eastern European Gynecologic Oncology Group (CEEGOG), Canadian Cancer Trials Group (CCTG)
Conditions Endometrial Cancer
Enrollment 316 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov