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Can hormone pills replace chemo for aggressive endometrial cancer?

NCT ID NCT07831902

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether radiotherapy followed by oral progestin tablets works as well as radiotherapy plus chemotherapy for people with high-risk endometrial cancer that lacks specific molecular markers. The trial enrolls about 600 participants and randomly assigns them to either the standard chemotherapy approach or radiotherapy followed by two years of daily progestin. The goal is to see if the hormone-based approach can control cancer while causing fewer side effects and improving quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oral progestin tablets (medroxyprogesterone acetate or megestrol acetate)
What this could lead to
If it works, women with high-risk endometrial cancer could receive a treatment that controls the disease with fewer side effects than chemotherapy.
What could go wrong
This is a Phase 3 trial, so the approach is still being tested. Progestin may not control cancer as well as chemotherapy in this group, and hormonal side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2034

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Written informed consent and consent for data sharing for the overarching RAINBO programme 2. 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 3. Full molecular classification performed following the diagnostic algorithm described in WHO 2020 (5th Edition, IARC, Lyon, 2020, adapted from Vermij et al. 2020) 4. Hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy or sentinel node biopsy, without macroscopic residual disease after surgery 5. No distant metastases as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis within 8 weeks of randomisation). Whole-body PET-CT scan is acceptable if this is part of standard of care at participating sites 6. Age ≥ 18 years 7. WHO performance status 0 or 1 8. Expected start of adjuvant treatment within 10 weeks after surgery 9. Patients must be accessible for treatment and follow-up 10. Consent for the donation of a tissue block for translational research for the overarching RAINBO programme 11. FIGO (2018) stage II EC with substantial LVSI or stage III NSMP tumours 12. p53 wildtype, MMR proficient EC with no somatic pathogenic POLE variant (i.e. NSMP) 13. ER+ by IHC (10% threshold applied) or Allred score of ≥3 14. Absolute neutrophil count (ANC) ≥1.5 x 109 /l 15. Platelets ≥ 100 x 109 /L 16. Bilirubin ≤ 1.5 x UNL (or ≤ 3 x ULN for cases of known Gilbert's syndrome) 17. AST/ALT ≤ 2.5 x UNL Exclusion Criteria: 1. Previous malignancy, except for non-melanoma skin cancer, in the past 5 years 2. Prior pelvic radiation 3. Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction) within previous 6 months 4. Thromboembolic event, e.g. pulmonary embolism or deep vein thrombosis, within previous 6 months 5. Impaired renal function: ≤50ml/min (EDTA clearance, or measured creatinine clearance) or creatinine clearance ≤60 ml/min (calculated according to Cockcroft gault) 6. Uncontrolled cardiac disease (defined as cardiac function which would preclude hydration during cisplatin administration and any contraindication to paclitaxel) 7. Peripheral neuropathy, ≥ grade 2 8. Inflammatory bowel disease 9. Known history of porphyria 10. History of active immune deficiency syndromes or uncontrolled HIV infection: HIV positive patients receiving effective antiretroviral therapy and CD4 count \>200 may be included 11. Patients who have received a live attenuated vaccine within 2 weeks prior to planned treatment start 12. Any other condition which as per section 4.3 of the relevant SmPC or in the opinion of the investigator contraindicates the use of chemotherapy, radiotherapy and/or oral progestin tablets 13. The patient is currently participating in another interventional clinical trial or has received an investigational drug (either approved or not approved) in any prior clinical study within 5 half-lives prior to screening

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bartholemew's Hospital

    RECRUITING

    London, United Kingdom

  • Cheltenham General

    RECRUITING

    Cheltenham, United Kingdom

  • Churchill

    RECRUITING

    Oxford, United Kingdom

  • James Cook University Hospital

    RECRUITING

    Middlesbrough, United Kingdom

  • Leicester Royal Infirmary

    RECRUITING

    Leicester, United Kingdom

  • Queen Alexandra Hospital

    RECRUITING

    Portsmouth, United Kingdom

  • Royal Marsden (Chelsea)

    RECRUITING

    London, United Kingdom

  • Royal Marsden (Sutton)

    RECRUITING

    Sutton, United Kingdom

  • Royal United Hospitals Bath

    RECRUITING

    Bath, United Kingdom

  • The Christie

    RECRUITING

    Manchester, United Kingdom

  • University College London Hospital (UCLH)

    RECRUITING

    London, United Kingdom

  • University Hospital Southampton

    RECRUITING

    Southampton, United Kingdom

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