New treatment approach for early-stage endometrial cancer with specific genetic profiles

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates a de-escalated adjuvant treatment strategy for patients with early-stage endometrial cancer who have either POLE mutations or p53 wildtype/NSMP profiles. Participants will be enrolled in one of two sub-studies, focusing on the effectiveness of vaginal brachytherapy, adjuvant radiotherapy, or observation compared to standard treatment protocols. The goal is to determine if this new approach offers better outcomes than the conventional methods typically used for this type of cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must have had surgery consisting of hysterectomy and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards. There must be no macroscopic residual disease after surgery.
* Patients must have histologically confirmed Stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed.
* Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* Patients' age must be ≥ 18 years.
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
* Patient is able (i.e. sufficiently fluent) and willing to complete the patient-reported outcomes (PRO) questionnaires in either English, French or a validated language
* Patients must be accessible for treatment and follow-up. Patients enrolled on this trial must be treated and followed at the participating centre
* Protocol treatment is to begin within 10 weeks of hysterectomy/bilateral salpingo-oophorectomy

Exclusion Criteria:

* Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.
* Prior pelvic radiation.
* Patients with a history of other malignancies, except: carcinoma in-situ without evidence of invasive disease when resected, adequately treated non-melanoma skin cancer, or other tumours curatively treated with no evidence of disease for ≥ 5 years.
* Clinical evidence of distant metastasis as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan)
* Patients with a documented positive surgical margin.
* Patients with a documented positive peritoneal washings, if performed.

Where it's running

• Alaska Womens Cancer Care
  Anchorage, Alaska, United States Recruiting
• University of Arizona Cancer Center
  Tucson, Arizona, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Huntington Memorial Hospital
  Pasadena, California, United States Recruiting
• Sutter Medical Center Sacramento
  Sacramento, California, United States Recruiting
• UCHealth University of Colorado Hospital
  Aurora, Colorado, United States Recruiting

+73 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Wendy Parulekar
• Email: wparulekar@ctg.queensu.ca
• Phone: 613-533-6430

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.