Tailoring Treatment for Patients with Low-Risk Endometrial Cancer After Surgery

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06388018

Provider View

This clinical trial is exploring how personalized treatment plans can help manage low-risk endometrial cancer after surgery. By analyzing tissue removed during surgery, doctors aim to decide if additional treatments like radiation or chemotherapy are necessary.

Patient Parameters

Program Overview

This study is investigating how well personalized treatment plans work for patients with low-risk endometrial cancer after surgery. Typically, surgery is the main treatment for this type of cancer. In this trial, the tissue removed during surgery is examined to help doctors decide if further treatment, such as radiation or chemotherapy, is needed.

Description

The main goal of this study is to see how often cancer returns in the pelvic area within three years when treatment is adjusted based on the tumor's molecular characteristics. Other goals include understanding the rates of cancer returning in other areas, survival rates, and how the molecular classification affects patients' decision-making and fear of cancer returning. The study also looks at the cost-effectiveness of personalized treatment and its impact on quality of life.

Patients are divided into two sub-studies:

Sub-Study A:

  • Cohort A1: Patients with a specific type of early-stage endometrial cancer (POLE-mutated) will be monitored without additional treatment.
  • Cohort A2: Patients with higher-risk POLE-mutated cancer may receive observation or radiation therapy.

Sub-Study B:

  • Patients with another type of endometrial cancer (p53 wildtype/NSMP ER+) may receive observation or radiation therapy.

All participants will have imaging tests like chest X-rays, CT, MRI, or PET/CT scans during the study. After treatment, follow-up visits will occur at 3 and 6 months, then every 6 months for 3 years, and annually thereafter.

Eligibility Criteria

Inclusion Criteria

  • Must have had surgery to remove the uterus and ovaries, with no visible cancer left.
  • Must have stage I to III endometrial cancer confirmed by lab tests.
  • Must be in good general health with a performance status of 0, 1, or 2.
  • Must be 18 years or older.
  • Must agree to participate and sign a consent form.
  • Must be able to complete questionnaires in English, French, or another validated language.
  • Must be able to attend treatment and follow-up appointments at the study center.
  • Treatment must start within 10 weeks of surgery.
  • Sub-Study A: Must have a specific molecular classification (POLE mutation).
  • Sub-Study B: Must have a specific molecular classification (p53 wildtype/NSMP) and be estrogen receptor positive.

Exclusion Criteria

  • Previous chemotherapy for current endometrial cancer.
  • Previous pelvic radiation.
  • History of other cancers, except for certain skin or cervical cancers, or other cancers treated successfully over 5 years ago.
  • Evidence of cancer spread to distant areas.
  • Sub-Study A: Isolated tumor cells in lymph nodes for Cohort A1.
  • Sub-Study B: Abnormal p53 or mismatch repair deficiency without POLE mutation.
  • Sub-Study B: Specific patterns of cancer spread or invasion.

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