Phase 2 Endometrial Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with a specific type of uterine cancer called uterine leiomyosarcoma, confirmed by a tissue sample taken less than 8 weeks before joining the study
• People who are generally well enough to carry out daily activities with little or no limitation (as measured by a standard medical scoring system)
• People who have never received chemotherapy for a sarcoma, and have not received the specific drugs doxorubicin (an anthracycline) or trabectedin for any other cancer
• People for whom a stored tumour tissue sample is available in sufficient quantity and quality for a specific genetic risk test called CINSARC NanoCind®
• People aged 18 to 75 years old
• People whose cancer was classified as an early stage (Stage I — IA or IB under the FIGO 2018 system) and who had the cancer completely removed by surgery (full hysterectomy, with or without removal of the ovaries)
• People with no signs of remaining or measurable disease, confirmed by CT scan or MRI imaging done within 4 weeks before joining the study
• People who have signed a consent form agreeing to take part in the trial
• People who have health insurance or are covered by a social security system, as required by local rules

Additional criteria that must be met before being assigned to a treatment group (randomisation):

• All of the above criteria still apply at the time of being assigned to a treatment group
• People whose CINSARC genetic test result shows a "high-risk" result
• People whose diagnosis has been confirmed by a specialist sarcoma pathologist recognised within the RRePS sarcoma pathology network
• People whose blood cell counts are within acceptable ranges — specifically, sufficient white blood cells, red blood cells, and platelets
• People whose kidneys are working well enough, based on blood test results
• People whose liver is working well enough, based on blood test results
• People whose heart is functioning well enough, based on heart scan results
• People with a specific muscle enzyme (CPK) level within an acceptable range on blood tests
• People with an adequate protein (albumin) level in their blood
• People who have signed a separate consent form for the randomised part of the trial

Who may not be able to join:

• People whose uterine cancer is a different type of uterine sarcoma (such as adenosarcoma, endometrial stromal sarcoma, or undifferentiated uterine sarcoma)
• People who have been diagnosed with or treated for another cancer in the past 5 years, with some exceptions such as certain treated skin cancers or early-stage cervical or bladder cancers
• People who are planned to have radiation therapy to the pelvis after surgery
• People whose cancer has spread to other parts of the body, or where measurable disease is visible on scans
• People with a known allergy or sensitivity to doxorubicin, trabectedin, or any of their ingredients
• People for whom either doxorubicin or trabectedin would be medically unsuitable for other reasons
• People who have taken part in another treatment trial within the 30 days before joining this study
• People with active hepatitis B, hepatitis C, or a known HIV infection
• People who have received any cancer treatment — including radiotherapy, hormone therapy, immunotherapy, chemotherapy, or experimental treatments — within the 4 weeks before joining (or 6 weeks for certain specific drugs)
• People with significant heart problems, including heart failure, a heart attack within the past 6 months, poorly controlled irregular heartbeats, uncontrolled high blood pressure, or chest pain at rest or newly started within the last 3 months
• People with an active, significant infection
• People who are currently breastfeeding
• People who are unable or unwilling to attend the medical appointments and follow-up required by the trial, for personal, family, geographic, or other reasons
• People who are under legal guardianship or have had their personal freedoms restricted

Additional reasons a person may not be able to enter the randomised treatment group:

• People who meet any of the above exclusion criteria at the time of randomisation
• People whose CINSARC genetic test result is unclear or unknown
• People whose diagnosis could not be confirmed by the central specialist pathologist (where a review was required)
• People for whom more than 13 weeks have passed since their surgery
• People who are currently taking certain medications that could interfere with the trial drugs — including phenytoin (within 88 hours), live vaccines (within 14 days), or certain antifungal, antiviral, antibiotic, or other drugs that affect how the body processes medications (confirm specific medications with the trial site)

Important: Always verify eligibility with the trial site directly before applying.