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RecruitingPHASE3INTERVENTIONAL

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

This study, called RAINBO NSMP-ORANGE, is for people who have had surgery for a specific type of womb cancer (endometrial cancer) that has a higher chance of coming back. The main goal is to see if a new treatment plan works as well as the current standard treatment, but with fewer unpleasant side effects. The standard treatment after surgery involves radiotherapy and chemotherapy. In this study, we're comparing that to a new approach: radiotherapy combined with hormone tablets (progestin). Patients will be randomly assigned to receive either the standard treatment or the new hormone tablet treatment. We hope this new approach can improve patients' quality of life by reducing treatment side effects.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
University College, London
Enrolment target
600
Start
29 Jun 2026
Estimated completion
01 Dec 2034

What is this study about?

When you have womb cancer (also known as endometrial cancer), treatment often involves surgery to remove the cancer. Afterwards, some people might need more treatment to try and stop the cancer from coming back. This is called 'adjuvant treatment'. For some types of womb cancer that are considered higher risk, the usual follow-up treatment involves a combination of radiotherapy (using radiation to kill cancer cells) and chemotherapy (using strong medicines).

This study is looking at whether a different approach might work just as well, but with fewer side effects. We're comparing the standard treatment (radiotherapy plus chemotherapy) with a new option: radiotherapy plus hormone tablets. These hormone tablets contain a type of progesterone, which is a natural hormone that can sometimes help control certain cancers.

The main idea behind this research is to improve your quality of life. Chemotherapy can have significant side effects, and we want to see if using hormone tablets instead can lead to fewer difficult symptoms while still being very effective at preventing the cancer from returning. If successful, this could mean a gentler treatment option for people with this specific type of womb cancer.

Key takeaways

  • This study is for people with a specific type of womb cancer after surgery.
  • It compares standard treatment (radiotherapy + chemotherapy) with a new approach (radiotherapy + hormone tablets).
  • The aim is to find a treatment that works well but causes fewer side effects.
  • Participation involves being randomly assigned to a treatment group.
  • Regular checks, blood tests, and scans will monitor your health.
  • You can withdraw from the study at any time.

Who may be eligible?

This study is for women aged 18 or older who have recently had surgery to remove womb cancer. To be considered, your cancer needs to be a specific type and have certain characteristics that doctors identify through special tests (called molecular features). Your doctors will also need to confirm that the cancer has not spread to other parts of your body and that you are generally well enough to take part in a study.

You will have already had an operation called a hysterectomy, which removes the womb and usually the ovaries and fallopian tubes. It's important that no cancer was left behind after this surgery. The study also requires you to have a good general health status, as measured by a scale called WHO performance status (scores of 0 or 1 mean you're able to carry out most or all daily activities).

There are also some reasons why you might not be able to join. For example, if you've had certain other cancers recently, or if you've had radiation treatment to your pelvis before. Also, if you've had serious blood clots (like angina or a heart attack) in the last six months, or have ongoing issues with blood clots, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Have you had surgery for womb cancer?
  2. Are you 18 years old or older?
  3. Has your doctor confirmed your cancer has certain specific features (NSMP type)?
  4. Are you generally well and able to carry out most daily activities?
  5. Have you *not* had certain other cancers or serious blood clots recently?
  6. Are you able to start treatment within 10 weeks of your surgery?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of two treatment groups, like flipping a coin. One group will receive the current standard treatment, which is radiotherapy followed by chemotherapy. The other group will receive radiotherapy followed by daily hormone tablets (either medroxyprogesterone acetate or megestrol acetate).

Before you start, and throughout the study, you'll have regular hospital visits for assessments, including blood tests and scans, to check how you're responding to treatment and to monitor for side effects. You'll also be asked to provide tissue samples from your surgery for further research. The specific number of visits and tests will be explained in detail by the study team. Treatment usually starts within 10 weeks after your surgery, and you will be followed up for an extended period to see how you're doing in the long term. You will need to consent to share your data for the broader research programme.

Potential risks and benefits

Participating in this study might offer you access to a potentially less toxic treatment approach that could improve your quality of life while being as effective as the standard. However, there's no guarantee that the new treatment will be better, or even as good as, the standard treatment. All treatments carry potential risks and side effects, and these will be carefully explained to you by the study team before you decide to take part. You will also have regular check-ups to monitor for any issues. Please remember that joining a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (12)

  • Royal United Hospitals Bath
    Verified postcode
    Bath, United Kingdom· Recruiting
  • Cheltenham General
    Verified postcode
    Cheltenham, United Kingdom· Recruiting
  • Leicester Royal Infirmary
    Verified postcode
    Leicester, United Kingdom· Recruiting
  • Bartholemew's Hospital
    Verified postcode
    London, United Kingdom· Recruiting
  • Royal Marsden (Chelsea)
    Verified postcode
    London, United Kingdom· Recruiting
  • University College London Hospital (UCLH)
    Verified postcode
    London, United Kingdom· Recruiting
  • The Christie
    Verified postcode
    Manchester, United Kingdom· Recruiting
  • James Cook University Hospital
    Verified postcode
    Middlesbrough, United Kingdom· Recruiting
  • Churchill
    Verified postcode
    Oxford, United Kingdom· Recruiting
  • Queen Alexandra Hospital
    Verified postcode
    Portsmouth, United Kingdom· Recruiting
  • University Hospital Southampton
    Verified postcode
    Southampton, United Kingdom· Recruiting
  • Royal Marsden (Sutton)
    Verified postcode
    Sutton, United Kingdom· Recruiting

Common questions

What is 'endometrial cancer'?

Endometrial cancer is a type of cancer that starts in the lining of the womb (uterus). It's also called womb cancer.

What does 'adjuvant treatment' mean?

Adjuvant treatment is extra treatment given after the main treatment (like surgery) to reduce the chance of the cancer coming back.

What are 'hormone tablets' in this study?

These are tablets containing a hormone called progestin. They are being tested to see if they can help stop cancer from returning, potentially with fewer side effects than chemotherapy.

What does 'randomly assigned' mean?

It means you would be put into one of the treatment groups by chance, like drawing names from a hat. Neither you nor your doctor chooses which group you're in.

What if I change my mind about taking part?

You can decide to leave the study at any time, for any reason. Your decision will not affect your medical care.

How to find out more

RAINBO NSMP-ORANGE Trial Manager

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Refining Adjuvant Treatment IN Endometrial Cancer Based On M…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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