Your session is about to expire
← Back to Search
Other
Genetic-Based Adjuvant Therapy for Endometrial Cancer
Phase 2
Recruiting
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 years
Awards & highlights
Study Summary
This trial tests a new approach to treating early-stage endometrial cancer, depending on the genetic makeup of the patient.
Who is the study for?
This trial is for adults with early-stage endometrial cancer that's either POLE-mutated or p53 wildtype/NSMP. Participants must have had a hysterectomy, no remaining visible disease, and an ECOG performance status of 0-2. They should be able to complete questionnaires in English, French or another validated language and start treatment within 10 weeks post-surgery.Check my eligibility
What is being tested?
The study examines de-escalated adjuvant treatments in two sub-studies: RAINBO BLUE for POLE-mutated cancer and TAPER for p53 wildtype/NSMP cancer. It compares the effects of adjuvant radiotherapy (with or without brachytherapy), vaginal brachytherapy alone, or just observation after surgery.See study design
What are the potential side effects?
Potential side effects may include those commonly associated with radiation therapy such as fatigue, skin irritation at the treatment site, mild swelling, discomfort during urination, diarrhea if pelvic area is treated, and possible long-term changes to bowel and bladder function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status
Secondary outcome measures
Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence Inventory
Estimate endometrial cancer-specific survival
Estimate overall survival
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Sub-study A: RAINBO BLUE Cohort A1Experimental Treatment1 Intervention
Observation
Group II: Sub-Study B: TAPERExperimental Treatment2 Interventions
Observation or Vaginal Brachytherapy
Group III: Sub-Study A: RAINBO BLUE Cohort A2 ExploratoryExperimental Treatment2 Interventions
Observation or Adjuvant Radiotherapy
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
126 Previous Clinical Trials
67,717 Total Patients Enrolled
Canadian Cancer Clinical Trials NetworkUNKNOWN
1 Previous Clinical Trials
200 Total Patients Enrolled
Jessica McAlpineStudy ChairBCCA-Vancouver Cancer Centre, Vancouver BC Canada
1 Previous Clinical Trials
249 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I had surgery to remove my uterus and ovaries with no visible cancer left.I have had cancer before, but it was either skin cancer treated successfully, cervical cancer treated without spreading, or any cancer treated over 5 years ago with no current signs of disease.I can care for myself and am up and about more than 50% of my waking hours.I have had chemotherapy before surgery for my current endometrial cancer.I have had radiation therapy to my pelvic area before.My endometrial cancer is confirmed and is between Stage I to III.My treatment will start within 10 weeks after my surgery to remove my uterus and ovaries.I am HIV-positive, on treatment, and my viral load is undetectable.I can and will fill out health questionnaires in English, French, or another validated language.
Research Study Groups:
This trial has the following groups:- Group 1: Sub-Study B: TAPER
- Group 2: Sub-study A: RAINBO BLUE Cohort A1
- Group 3: Sub-Study A: RAINBO BLUE Cohort A2 Exploratory
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any vacancies in this research project?
"According to data hosted on clinicaltrials.gov, this trial is still open for recruitment with the original post date being December 19th 2022 and a recent update posted on March 15th 2023."
Answered by AI
Has Sub-Study B: TAPER been given clearance by the FDA?
"Sub-Study B: TAPER was accorded a safety rating of 2, as there is clinical evidence that argues for its safety but no data affirming its efficacy."
Answered by AI
To what extent is the study population comprised of participants?
"Affirmative. Based on information available from clinicaltrials.gov, this medical research is actively seeking participants. Initially posted in December 19th 2022, the study requires 325 individuals to be recruited at a single location since its last update in March 15th 2023."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger