RecruitingPHASE2, PHASE3INTERVENTIONAL

Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features

The RAINBO study is investigating new ways to treat endometrial cancer after surgery. It's like an 'umbrella' study with four smaller trials, and patients are assigned to one based on the specific features of their cancer. Researchers are trying to discover if these new, more tailored treatments work better than standard care. They will compare new drugs like Olaparib and Durvalumab, hormone therapy, or even reduced treatment, depending on the cancer's genetic makeup. The goal is to improve effectiveness, reduce side effects, and improve quality of life for women with endometrial cancer.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Leiden University Medical Center

Enrolment target

1,615

Start

11 Nov 2021

Estimated completion

01 Jan 2031

Endometrial Cancer

What is this study about?

The RAINBO (Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features) research project is looking into better ways to treat endometrial cancer after surgery. Endometrial cancer is a type of cancer that starts in the lining of the womb. 'Adjuvant treatment' means extra treatment given after surgery to try and stop the cancer from coming back. This project is exploring whether tailoring these treatments to the specific characteristics of a patient's cancer can be more effective.

Imagine endometrial cancer isn't just one disease, but several different types, each with its own weaknesses. This study uses a special test to look at the 'molecular features' of a patient's cancer – basically, its genetic fingerprint. Based on these unique features, patients are put into one of four groups, like different colours of the rainbow: RED, GREEN, ORANGE, or BLUE. Each group then tests a different treatment approach, which might include new medications, hormone therapy, or even less treatment if the cancer is less aggressive.

The overall aim of RAINBO is to find new and improved treatments that are more personalised for each patient. Researchers will compare these new treatments to the usual care, looking at how well they work, if they have fewer side effects, how they impact a patient's quality of life, and even their cost. This study is important because it could help doctors choose the best possible treatment for each woman, making treatment more effective and potentially reducing unnecessary side effects.

Key takeaways

This study investigates new treatments for endometrial cancer after surgery.
Treatment plans are tailored to the specific genetic features of each patient's cancer.
It compares new treatments to current standard care.
The goal is to find more effective treatments with fewer side effects.
Participation involves regular checks and monitoring.
You can withdraw from the study at any time.

Who may be eligible?

To join the RAINBO study, you would first need to have been diagnosed with endometrial cancer. This diagnosis must be confirmed by a specialist, and specific tests would be done to understand the unique characteristics of your cancer.

You would also need to have had surgery to remove your womb and ovaries, and there should be no signs of cancer spread to other parts of your body, as shown by scans. Your general health should be good enough to take part in a study, meaning you can carry out most everyday activities. Your doctors would need to be able to start any study treatment within 10 weeks of your surgery.

There are a few reasons why someone might not be able to join. For example, if you've had another major cancer in the last five years (excluding some skin cancers) or if you've had radiation treatment to your pelvis before, you wouldn't be eligible. Each of the four smaller trials within RAINBO also has its own specific requirements, so your doctors would check all these details carefully.

Quick self-check

Have I been diagnosed with endometrial cancer?
Have I had surgery (hysterectomy and removal of ovaries)?
Are there no signs of cancer spread to other parts of my body?
Is my general health good enough for everyday activities?
Have I not had another major cancer in the last 5 years (some exceptions apply)?
Have I not had previous radiation therapy to my pelvis?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in the RAINBO study, the exact details of what you'll do will depend on which of the four 'colour' trials your cancer's features place you into. Generally, after your surgery, your doctors would test your cancer for its unique features.

Once assigned to a specific trial, you would either receive the standard treatment or one of the new experimental treatments. These treatments vary and could include medications like Olaparib or Durvalumab, a type of radiation therapy, chemotherapy, or hormone treatments. Some specific trials might even explore less treatment if your cancer is found to be very low risk. The duration of treatments can vary; some might be for a year, others can be for two years, and some short-term.

Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. You'll also be asked about your quality of life. The study design aims to carefully track your progress over time, and you'll be followed up regularly for a period after your main treatment finishes.

Potential risks and benefits

Taking part in a clinical trial means you might be among the first to receive a new treatment that could be more effective than current options, or it might help scientists learn more about better ways to treat endometrial cancer. However, new treatments can also have unexpected side effects or might not work as well as expected. Standard treatments also have known risks and benefits. Medical staff will monitor you very closely throughout the study for any side effects. Remember, joining a clinical trial is always voluntary, and you can withdraw at any time without affecting your future medical care.

Locations (14)

The POLEmut-BLUE trial: Princess Margaret Cancer Centre, University of Toronto
Toronto, Canada· Recruiting
The POLEmut-BLUE trial: University of British Columbia
Vancouver, Canada· Recruiting
The p53abn-RED trial: Institute Gustave Roussy
Villejuif, France· Not yet recruiting
Amsterdam University Medical Center
Amsterdam, Netherlands· Recruiting
Amphia Ziekenhuis
Breda, Netherlands· Recruiting
Instituut Verbeeten
Breda, Netherlands· Recruiting
Catharina Ziekenhuis
Eindhoven, Netherlands· Recruiting
Medisch Spectrum Twente
Enschede, Netherlands· Recruiting
Universitair Medisch Centrum Groningen
Groningen, Netherlands· Recruiting
The MMRd-GREEN trial: Leiden University Medical Center
Leiden, Netherlands· Recruiting
Erasmus Medical Center
Rotterdam, Netherlands· Recruiting
Haags Medisch Centrum
The Hague, Netherlands· Recruiting

+2 more sites — see the official record for the full list.

Common questions

What is endometrial cancer?

Endometrial cancer is a type of cancer that starts in the lining of the womb (uterus).

What does 'adjuvant treatment' mean?

Adjuvant treatment is extra treatment given after surgery to help stop the cancer from coming back.

How will I know which RAINBO trial I would be in?

Doctors will test your cancer's specific genetic features, and this will determine which of the four RAINBO trials is suitable for you.

Will I definitely receive one of the new treatments?

Not necessarily. Some parts of the study compare new treatments with standard treatments, so you might receive the current standard care.

Can I stop participating in the study if I change my mind?

Yes, you can choose to stop participating in the study at any time without it affecting your medical care.

How to find out more

Carien L Creutzberg, MD PhD

c.l.creutzberg@lumc.nl +31 71 52 65539 Official trial record

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