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RecruitingPHASE2INTERVENTIONAL

Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER

This study is investigating new, less intense ways to treat early-stage womb cancer for certain patients. If you've had surgery for womb cancer, and tests show your cancer has particular genetic features (POLE-mutated or p53 wildtype/NSMP), you might be able to take part. The study aims to compare watching carefully, or having less radiation treatment than usual, to the standard approach. This is to see if these gentler methods are just as good at preventing the cancer from coming back, while potentially reducing side effects. It's about finding the best balance for your care.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Canadian Cancer Trials Group
Enrolment target
393
Start
19 Dec 2022
Estimated completion
30 Jun 2029

What is this study about?

This study, called RAINBO BLUE & TAPER, is for people who have been diagnosed with early-stage womb cancer. When you have womb cancer, the usual first step is surgery to remove the womb and ovaries. After surgery, doctors carefully examine the removed tissue to understand the cancer better. This helps them decide if you need any further treatment, like radiation therapy.

This research is looking at whether we can offer gentler follow-up treatments for certain types of early-stage womb cancer. Some cancers have specific genetic features. This study focuses on cancers with a 'POLE mutation' or 'p53 wildtype/no specific molecular profile' (NSMP). For these particular types of womb cancer, we want to know if having less treatment, or sometimes just being carefully watched, works as well as the standard, more intensive radiation treatments.

By finding out if these gentler approaches are effective, the aim is to give patients the best chance of recovery while also reducing potential side effects from treatment. It's about tailoring treatment more precisely to your specific cancer type.

Key takeaways

  • New study for certain early-stage womb cancers.
  • Investigates gentler treatments or close monitoring after surgery.
  • Aims to reduce side effects while maintaining effectiveness.
  • Focuses on specific genetic types of womb cancer.
  • You can discuss participation with your doctor; it's always your choice.

Who may be eligible?

This study is looking for women aged 18 or older who have recently had surgery to remove their womb and ovaries for early-stage womb cancer. Your cancer must be one of the specific types they are studying (POLE-mutated or p53 wildtype/NSMP). You should also be well enough to carry out your normal daily activities.

There are some reasons why you might not be able to join. For example, if you've already had radiation treatment in your pelvic area, or if your cancer has spread to other parts of your body, this study might not be suitable. Also, if there's still visible cancer remaining after your surgery, or if parts of your cancer cells are found in certain fluid washes, you wouldn't be able to participate. They also can't include you if you've had certain other cancers recently.

All participants will need to give their informed consent, meaning you understand the study and agree to take part. You also need to be able to complete questionnaires in English, French, or another available language, and be able to attend follow-up appointments at the participating hospital.

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. Are you 18 years old or older?
  2. Have you recently had surgery (womb and ovaries removed) for early-stage womb cancer?
  3. Do pathology test results show your cancer is POLE-mutated or p53 wildtype/NSMP?
  4. Are you generally well and able to manage daily activities?
  5. Have you not had previous radiation to your pelvic area?
  6. Is there no clinical sign that your cancer has spread far?
Answer every question to see your result.

What does participation involve?

If you join this study, your involvement would begin within 10 weeks of your surgery. You might be asked to have vaginal brachytherapy (a type of internal radiation), external beam radiation therapy, or you might be placed in a group where doctors simply observe you closely without further treatment, depending on which sub-study you join and what is agreed upon. The specific treatments and follow-up plan will be thoroughly explained to you.

Throughout the study, you'll have regular hospital visits for check-ups and to monitor your health and recovery. You may also be asked to fill in questionnaires about how you are feeling and your quality of life. The total duration of your participation, including treatment and follow-up, will be detailed by the study team.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a potentially gentler or more tailored treatment approach, which could lead to fewer side effects compared to standard care, while aiming for the same good outcome for your cancer. However, there's always a possibility that the newer approaches aren't as effective as current standard treatments, or that you might experience side effects from the treatments given. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (110)

  • Alaska Womens Cancer Care
    Verified postcode
    Anchorage, United States· Recruiting
  • University of Arizona Cancer Center
    Verified postcode
    Tucson, United States· Recruiting
  • Cedars-Sinai Medical Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • Huntington Memorial Hospital
    Verified postcode
    Pasadena, United States· Recruiting
  • Sutter Medical Center Sacramento
    Verified postcode
    Sacramento, United States· Recruiting
  • UCHealth University of Colorado Hospital
    Verified postcode
    Aurora, United States· Recruiting
  • AdventHealth Porter
    Verified postcode
    Denver, United States· Recruiting
  • University of Miami School of Medicine
    Verified postcode
    Miami, United States· Recruiting
  • Sarasota Memorial Hospital - Venice
    City only
    N. Venice, United States· Recruiting
  • Florida Cancer Specialists - Sarasota Downtown
    Verified postcode
    Sarasota, United States· Recruiting
  • First Physicians Group-Sarasota
    Verified postcode
    Sarasota, United States· Recruiting
  • Sarasota Memorial Hospital
    Verified postcode
    Sarasota, United States· Recruiting

Common questions

What is 'early-stage endometrial cancer'?

This means your womb cancer has been found at an early point and has not spread far from the womb.

What are POLE-mutated and p53 wildtype/NSMP?

These are specific genetic features found in your cancer cells that doctors look for. They help predict how your cancer might behave.

What does 'de-escalated adjuvant treatment' mean?

It means trying less intensive follow-up treatment after surgery, generally to reduce side effects, while still trying to achieve the best possible results.

Will I still get treatment if I'm in the 'observation' group?

Yes, 'observation' means carefully monitoring your health with regular check-ups, so doctors can act quickly if needed. It doesn't mean no care.

Can I choose which treatment I get?

The study will assign you to a sub-study based on your cancer type and then to a specific treatment path. The doctors and study team will discuss all options with you.

How to find out more

Wendy Parulekar

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 "Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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