ClinicalTrials.gg
RecruitingNCT07831902NSMP-ORANGEUpdated Sep 21, 2026

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

A Phase 3 interventional study of medroxyprogesterone acetate tablets OR megestrol acetate and Cisplatin in Endometrial Cancer and Uterine Neoplasms, sponsored by University College, London. Recruiting at 12 sites in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by University College, London · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.

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Phase
Phase 3
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 111 studies in Endometrial Neoplasms with a site in United Kingdom — 29 open to participants now, 47 under way, 13 of them phase 3. Endometrial Neoplasms · United Kingdom.

Planned enrollment
17th of 87
600 · median 250
Started
2026
with 5 others
Phase 3
24 of 111
6 open now
Primary completion
2030-12
later than 44 of 46 live
Registered
109th of 111
by date
Lead sponsor
4 of 111
University College, London

Among the 111 studies in Endometrial Neoplasms with a site in United Kingdom, this one is the 17th largest by planned enrollment of the 87 interventional ones that give a count, is one of 6 that started in 2026, is one of 24 in phase 3, reaches primary completion later than 44 of the 46 other live ones, and was the 109th registered.

Endometrial Neoplasms

1,425 studies on the registry are indexed under Endometrial Neoplasms; 472 are open to participants now.

Browse Endometrial Neoplasms studies →

Open to participants now

29 of the 111 studies in Endometrial Neoplasms with a site in United Kingdom are open now. Recruiting first, the newest first:

23 more — sign in →

All 29 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 358 Endometrial Neoplasms studies recruiting now, 268 (75%) set no upper age limit and 54 (15%) stop at 75 or younger; 26 take children under 18; 23 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

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02

Study summary

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.

03

Conditions studied

  • Endometrial Cancer
  • Uterine Neoplasms

Keywords

  • NSMP
  • oral progestin
  • endometrial cancer
  • no specific molecular profile
  • womb cancer
  • hormone tablets
  • hormone therapy
  • uterine cancer
  • progestin
  • Molecular risk factors
  • Chemoradiation
  • Radiotherapy
  • Chemotherapy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Written and consent for data sharing for the overarching RAINBO programme
  2. 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 , without macroscopic residual disease after surgery
  5. No distant 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. 0 or 1
  8. Expected start of 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. (ANC) ≥1.5 x 109 /l
  15. ≥ 100 x 109 /L
  16. ≤ 1.5 x UNL (or ≤ 3 x for cases of known Gilbert's syndrome)
  17. /ALT ≤ 2.5 x UNL

Exclusion criteria

Exclusion Criteria:

  1. Previous , 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 ) 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 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 infection: HIV positive patients receiving effective antiretroviral therapy and >200 may be included
  11. Patients who have received a 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 drug (either approved or not approved) in any prior clinical study within 5 half-lives prior to screening
Terms in these criteria, in plain language(18)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Arm A

    Adjuvant pelvic radiotherapy +/- vaginal brachytherapy followed by oral progestin tablets for 24 months (investigational arm)

    Drug: medroxyprogesterone acetate tablets OR megestrol acetate

  • Active comparator
    Arm B

    Adjuvant pelvic radiotherapy +/- vaginal brachytherapy with chemotherapy (cisplatin, carboplatin and paclitaxel, standard of care arm)

    Drug: Cisplatin · Drug: Carboplatin + Paclitaxel

Interventions

  • Drugmedroxyprogesterone acetate tablets OR megestrol acetate

    Medroxyprogesterone acetate 200mg once daily OR megestrol acetate 160mg once daily following completion of radiotherapy, for 24 months (2 years)

    Also known as: oral progestin

  • carboplatin and paclitaxel +/- cisplatin, as per standard of care/investigator decision, with radiotherapy

  • DrugCarboplatin + Paclitaxel

    Drug pages: Carboplatin · Paclitaxel

    carboplatin and paclitaxel +/- cisplatin, as per standard of care/investigator decision, with radiotherapy

06

What researchers measure

Primary outcomes

  1. Recurrence free survival (RFS)

    RFS is defined as the time from date of randomisation to date of recurrence or death from any cause.

    Time frame: 3 years

Secondary outcomes

  1. Recurrence free survival (RFS)

    RFS is defined as the time from date of randomisation to date of recurrence or death from any cause.

    Time frame: 5 years

  2. Vaginal recurrence free survival (RFS)

    Defined as the time from date of randomisation to date of vaginal recurrence.

    Time frame: 3 years, 5 years

  3. Pelvic recurrence free survival (RFS)

    Defined as the time from date of randomisation to date of pelvic recurrence.

    Time frame: 3 years, 5 years

  4. Para-aortic nodal recurrence free survival (RFS)

    Defined as the time from date of randomisation to date of para-aortic nodal recurrence

    Time frame: 3 years, 5 years

  5. Distant recurrence free survival (RFS)

    Defined as the time from date of randomisation to date of distant recurrence

    Time frame: 3 years, 5 years

  6. Cancer-specific survival

    Defined as the time from date of randomisation to date of cancer-related death

    Time frame: 3 years, 5 years

  7. Overall survival

    Defined as the time from date of randomisation to date of death from any cause

    Time frame: 3 years, 5 years

  8. Treatment-related toxicity (using the Common Terminology Criteria for Adverse Events [CTCAE] version 5.0)

    Toxicity at any time will be described by trial arm in the safety population which will include all patients who receive any trial treatment.

    Time frame: 3 years, 5 years

  9. Health-related quality of life (using the validated common and endometrial cancer European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaires C30 and EN24)

    Time frame: 3 years, 5 years

07

Study locations

12 of 12 sites recruiting
  • Royal United Hospitals Bath
    Bath, United Kingdom
    Recruiting
    • Jennifer Van Griethuysen · Principal investigator
  • Cheltenham General
    Cheltenham, United Kingdom
    Recruiting
    • Audrey Cook · Principal investigator
  • Leicester Royal Infirmary
    Leicester, United Kingdom
    Recruiting
    • Anupama Gore · Principal investigator
  • Bartholemew's Hospital
    London, United Kingdom
    Recruiting
    • Millie Light · Principal investigator
  • Royal Marsden (Chelsea)
    London, United Kingdom
    Recruiting
    • Alexandra Taylor · Principal investigator
  • University College London Hospital (UCLH)
    London, United Kingdom
    Recruiting
    • Gemma Eminowicz · Principal investigator
  • The Christie
    Manchester, United Kingdom
    Recruiting
    • Andrew Clamp · Principal investigator
  • James Cook University Hospital
    Middlesbrough, United Kingdom
    Recruiting
    • Darren Leaning · Principal investigator
  • Churchill
    Oxford, United Kingdom
    Recruiting
    • Sally Trent · Principal investigator
  • Queen Alexandra Hospital
    Portsmouth, United Kingdom
    Recruiting
    • Radwa Ahmed · Principal investigator
  • University Hospital Southampton
    Southampton, United Kingdom
    Recruiting
    • Vicky McFarlane · Principal investigator
  • Royal Marsden (Sutton)
    Sutton, United Kingdom
    Recruiting
    • Alexandra Taylor · Principal investigator
08

References and documents

Individual participant data

Plan to share: Yes — Following the planned translational work in the RAINBO programme and publications, the translational research (TR) committee will open up the sample collection to external researchers. Access will be granted following completion of a research proposal form and approval by the TR committee chaired by Dr. Tjalling Bosse. All external researchers will be expected to demonstrate funding for their project and ethics approval. Data will be made available as required through data sharing agreements. The following will be reviewed when considering applications for data sharing and sample access: data and sample use is in-keeping with patient consent, the proposed project has scientific value, with defined objectives and study plan, trial data are appropriate for the intended purpose, acknowledgement of the RAINBO Programme in all publications that arise from the data sharing, compliance with legal and regulatory requirements as applicable and patient confidentiality maintained at all times.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Dec 2030, 54 months after the start.

Of 44 phase 3 interventional studies under Endometrial Neoplasms, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 126. This study's planned 54 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2026
First posted
Sep 21, 2026
StartActual
Jun 29, 2026
Primary completionEst.
Dec 2030
CompletionEst.
Dec 2034
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07831902
Responsible party
Sponsor
First posted
Sep 21, 2026
Start date
Jun 29, 2026
Primary completion
Dec 2030 (estimated)
Completion
Dec 2034 (estimated)
Last update
Sep 21, 2026

Study contacts

RAINBO NSMP-ORANGE Trial Manager
Contact
ctc.nsmp-orange@ucl.ac.uk
+44 2076799808

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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