OncoMatch/Clinical Trials/NCT07831902
Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features (RAINBO) - NSMP-ORANGE Trial: Comparing Radiotherapy With Oral Progestin Tablets vs. the Current Standard Care, Radiotherapy and Chemotherapy, in Patients With NSMP Endometrial Cancer
Official title: Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features (RAINBO) No Specific Molecular Profile (NSMP) - ORANGE Trial
Is NCT07831902 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies multiple treatments including medroxyprogesterone acetate tablets OR megestrol acetate and Cisplatin for endometrial cancer.
Treatment: medroxyprogesterone acetate tablets OR megestrol acetate · Cisplatin · Carboplatin + Paclitaxel — RAINBO NSMP-ORANGE aims to investigate if adjuvant radiotherapy with oral progestin tablets is as effective as radiotherapy with chemotherapy, whilst reducing toxicity and thus improving quality of life, in patients with high-risk NSMP endometrial cancer. Patients will be randomised to radiotherapy with chemotherapy (standard of care), or radiotherapy followed by oral progestin tablets.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Endometrial Cancer
Biomarker criteria
Required: TP53 wild-type
p53 wildtype
Required: POLE wild-type
no somatic pathogenic POLE variant (i.e. NSMP)
Required: ESR1 expression (IHC ≥10% or Allred score ≥3)
ER+ by IHC (10% threshold applied) or Allred score of ≥3
Required: Mismatch-repair proficient (pMMR / MSS)
MMR proficient EC
Disease stage
Required: Stage II, III
Performance status
WHO 0–1
Demographics
Prior therapy
Cannot have received: pelvic radiation
Prior pelvic radiation
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1.5 x 10^9 /l; Platelets ≥ 100 x 10^9 /L
Kidney function
Impaired renal function: ≤50ml/min (EDTA clearance, or measured creatinine clearance) or creatinine clearance ≤60 ml/min (calculated according to Cockcroft gault) [excluded]
Liver function
Bilirubin ≤ 1.5 x UNL (or ≤ 3 x ULN for cases of known Gilbert's syndrome); AST/ALT ≤ 2.5 x UNL
Absolute neutrophil count (ANC) ≥1.5 x 10^9 /l; Platelets ≥ 100 x 10^9 /L; Bilirubin ≤ 1.5 x UNL (or ≤ 3 x ULN for cases of known Gilbert's syndrome); AST/ALT ≤ 2.5 x UNL; Impaired renal function: ≤50ml/min (EDTA clearance, or measured creatinine clearance) or creatinine clearance ≤60 ml/min (calculated according to Cockcroft gault) [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07831902 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior pelvic radiation disqualifies patients from enrollment.
Does this trial require TP53?
Yes, TP53 wild-type is a required biomarker for enrollment.
Does this trial require MLH1?
Yes, MLH1 wild-type is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages