Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features

Official Title

Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features: the p53abn-RED Trial, the MMRd-GREEN Trial, the NSMP-ORANGE Trial and the POLEmut-BLUE Trial

Summary:

The RAINBO umbrella program consists of four clinical trials investigating new adjuvant therapies in endometrial cancer patients. Eligible patients will be assigned to one of the four RAINBO trials based on the molecular profile of their cancer:
  • p53 abnormal endometrial cancer patients to the p53abn-RED trial
  • mismatch repair deficient endometrial cancer patients to the MMRd-GREEN trial
  • no specific molecular profile endometrial cancer patients to NSMP-ORANGE trial
  • POLE mutant endometrial cancer patients to the POLEmut-BLUE trial

Trial Description

Primary Outcome:

  • p53abn-RED trial
  • MMRd-GREEN trial
  • NSMP-ORANGE trial
  • POLEmut-BLUE trial
Secondary Outcome:
  • Recurrence-free survival
  • Pelvic recurrence-free survival
  • Vaginal recurrence-free survival
  • Endometrial cancer-specific survival
  • Overall survival
  • Treatment-related toxicity - according to CTCAE v5.0
  • Health-related quality of life - Assessed using the EORTC QLQ-C30 questionnaire
  • Health-related quality of life - Assessed using the EORTC QLQ-EN24 questionnaire

The p53abn-RED trial is an international, multicenter, phase III randomised trial wherein adjuvant chemoradiation followed by olaparib for two years is compared to adjuvant chemoradiation.

The MMRd-GREEN trial 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.

The NSMP-ORANGE trial is an international, multicenter, phase III randomised trial wherein adjuvant pelvic external beam radiotherapy followed by progestogens for two years is compared to adjuvant chemoradiation.

The POLEmut-BLUE trial is an international, multicenter, single arm, phase II trial wherein safety of de-escalation of adjuvant therapy is investigated: no adjuvant therapy for stage I-II disease and no adjuvant therapy or pelvic external beam radiotherapy only for stage III disease.

The overarching RAINBO research project will combine the data and tumour 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society