Study on Adjuvant Therapy for Early Stage Endometrial Cancer with Specific Genetic Profiles
Sponsor: Canadian Cancer Trials Group
ClinicalTrials ID:NCT05640999
This clinical trial is exploring a new approach to treatment for patients with early-stage endometrial cancer that has specific genetic characteristics. The study aims to determine if this new method is better or worse than the usual treatment approach.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is testing a new, less intensive treatment for patients with early-stage endometrial cancer that has certain genetic features, specifically POLE mutations or p53 wildtype/no specific molecular profile (NSMP). Patients can participate in one of two sub-studies based on their cancer's genetic profile: RAINBO BLUE for POLE-mutated cancer and TAPER for p53 wildtype/NSMP cancer.
Description
The purpose of this study is to find out if a new treatment approach is more effective or less effective than the standard treatment for early-stage endometrial cancer. Typically, patients with early-stage endometrial cancer undergo surgery, and the removed tissue is examined to decide if additional treatments like radiation or chemotherapy are needed. This study is looking at a different approach to see if it can provide better outcomes for patients.
Eligibility Criteria
Inclusion Criteria
- Must have had surgery to remove the uterus and ovaries, with no visible cancer left after surgery.
- Must have confirmed Stage I to III endometrial cancer, which can be of various types like endometrioid, serous, or clear cell.
- Must have a performance status score of 0, 1, or 2, indicating good overall health.
- HIV-positive patients can participate if they are on effective treatment with an undetectable viral load.
- Must be 18 years or older.
- Must provide informed consent to participate.
- Must be able to complete questionnaires in English, French, or another validated language.
- Must be available for treatment and follow-up at the study center.
- Treatment must start within 10 weeks after surgery.
Exclusion Criteria
- Have received chemotherapy before surgery for the current cancer diagnosis.
- Have had radiation treatment to the pelvic area.
- Have a history of other cancers, except for certain skin cancers or other cancers treated successfully with no return for at least 5 years.
- Have evidence of cancer spread to distant parts of the body based on imaging tests.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cedars-Sinai Medical Center | 90048 | Los Angeles | California |
| UCHealth University of Colorado Hospital | 80045 | Aurora | Colorado |
| Northwestern University | 60611 | Chicago | Illinois |
| UMass Memorial Medical Centre | 01605 | Worcester | Massachusetts |
| Sidney Kimmel Cancer Center Washington Township | 08080 | Sewell | New Jersey |
| UNC Lineberger Comprehensive Cancer Center | 27599 | Chapel Hill | North Carolina |
| Duke University Medical Center | 27710 | Durham | North Carolina |
| Duke Womens Cancer Care Raleigh | 27607 | Raleigh | North Carolina |
| Ohio State University Comprehensive | 43210 | Columbus | Ohio |
| University of Oklahoma Health Sciences Center | 73104 | Oklahoma City | Oklahoma |
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