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RAINBO: Refining Adjuvant treatment IN endometrial cancer Based On molecular features, TransPORTEC platform trials

Achtergrondgegevens

Recently, trans-PORTEC data from our group provides strong evidence that endometrial cancer should be treated based on its molecular subtype. Besides this endometrial cancer is known for its underlying molecular biology for which the TCGA classification describes four distinct molecular subgroups with prognostic significance. The RAINBO platform comprises 4 trials: the RED/ p35abn trial, investigating adjuvant chemoradiation followed by niraparib vs placebo (PI dr. A. Leary, GINECO); the GREEN/MMRd trial, investigating adjuvant radiotherapy followed by dostarlimab vs placebo (PI dr. J.R. Kroep, DGOG); the ORANGE/NSMP trial, investigating adjuvant radiotherapy with or without endocrine therapy (PI dr. M. Powell, NCRI); and the BLUE/POLE mutant trial, aiming to de-escalating adjuvant treatment, thus being a single-arm trial of observation after surgery (PI dr. H. Mackay, CCTG).

Uitgangsvraag

Objectives
Primary:

  • To determine the efficacy, in terms of investigator assessed 3 year recurrence free survival (RFS), in patients with early EC.
  • In the separate trials
  • Overarching Red, Green and Orange trial, control vs intervention arm

Secondary:

  • RFS at 5 years
  • OS (median, 3yr, 5yr)
  • HRQoL
  • Safety & tolerability (NCI-CTC grade 3-5)
  • Translational research

Studie design

International, multicentre, program with 3 randomized trials (RED, GREEN, Orange) and one observational trial (BLUE) in patients with stage Ia (with myometrial invasion)- III endometrial cancer.

Patients will be centrally registered and after molecular analysis will be recruited into the international program and be allocated to one of the four trials on the basis of their molecular profile.

 

Power calculation

RED: with 485 patients, the trial is designed to have 80% power with a 2-sided alpha of 0.05 to detect an improvement in 5 yr RFS rate (HR=0.64).
GREEN: with 296 patients, the trial is designed to have 80% power at 2-sided alpha of 0,050 to detect an improvement in 3 year RFS from 65% to 78% (HR=0.58).
ORANGE: N=698
BLUE: N=100

Algemene gegevens

International trial
GINECO sponsor with delegate sponsorship contracts with DGOG, NCRI, NCIC, German group ect

Sponsor:
GSK
National grants
In the Netherlands KWF grant application

Estimated 4 years inclusion.

Organisatie

RAINBO Chair: prof.dr. Carien Creutzberg
P53abd-RED trial PI: dr Alexandra Leary
MMRd-GREEN trial PI: dr Judith Kroep
NSMP-ORANGE trial PI: dr Melanie Powell
POLEmut-BLUE trial PI: prof.dr Helen Mackay