Phase 3 Endometrial Cancer Trial, Recruiting

Written by an AI model from the 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 endometrial cancer (uterine cancer) confirmed by a tissue sample, including specific types such as endometrioid, serous, clear cell, de-/undifferentiated carcinomas, or uterine carcinosarcoma (all grades accepted)
• People whose cancer has been tested and classified at the molecular level using a specific standard testing method (WHO 2020 guidelines)
• People whose cancer has been specifically classified as "p53 abnormal" (p53abn), and whose tumour testing shows normal DNA mismatch repair (pMMR) and no POLE mutations
• People who have had surgery to remove the uterus and ovaries (with or without removal of nearby lymph nodes), with no visible cancer remaining after the operation
• People whose cancer is Stage I, II, or III and has grown into the muscle wall of the uterus
• People with no signs of cancer spread to distant parts of the body, confirmed by a CT or PET-CT scan before or after surgery
• People who are receiving, or have already received, a specific combination treatment of chemotherapy (typically involving cisplatin, carboplatin, and paclitaxel) and radiotherapy, started within 6–10 weeks after surgery (confirm with trial site for acceptable variations to the chemotherapy schedule)
• People aged 18 years or older
• People with a body weight above 30 kg
• People with a general health/activity level rated as 0 or 1 on the WHO Performance Scale (meaning fully active or able to carry out light work)
• People with a life expectancy of at least 16 weeks
• People with adequate kidney function, as measured by blood or urine tests within 28 days before starting the study treatment (confirm with trial site for specific values)
• People with adequate bone marrow function, including sufficient red blood cells, white blood cells, and platelets, with no blood transfusion in the 28 days before testing (confirm with trial site for specific values)
• People with adequate liver function, confirmed by blood tests within 28 days before starting the study treatment (confirm with trial site for specific values)
• People who are able to attend all required treatment visits and follow-up appointments
• People who are enrolled in, or covered by, a social security or health insurance system
• People who have signed a written consent form agreeing to take part in the trial and its associated research project, before any study procedures begin

Who may not be able to join:

• People whose cancer has reached Stage IV (the most advanced stage), regardless of whether surgery removed all visible disease
• People who have previously had radiation therapy to the pelvic area
• People who have had another cancer in the past, unless it was fully treated with no signs of return for 5 or more years — exceptions may apply for certain early-stage or skin cancers (confirm with trial site)
• People with certain uncontrolled or serious heart conditions, such as unstable angina, uncontrolled irregular heartbeat, heart failure, or a specific abnormal heart rhythm reading on an ECG, or people born with a condition called long QT syndrome
• People still experiencing significant ongoing side effects (above a certain severity level) from previous cancer treatment, not including hair loss
• People with a weakened immune system, including those known to be HIV positive
• People who have received chemotherapy or radiotherapy (other than for symptom relief) within 3 weeks before starting the study treatment
• People considered to be in poor general health due to a serious uncontrolled medical condition, active uncontrolled infection, or certain other conditions such as recent heart attack (within 3 months), uncontrolled seizures, or certain psychiatric conditions
• People who have had a major surgical procedure within 2 weeks before joining the trial, or who have not yet fully recovered from surgery
• People who have had a serious physical injury within 4 weeks of starting the study drug
• People who have previously received an organ transplant from another person
• People with severe liver disease
• People who have previously taken a type of drug called a PARP inhibitor (including olaparib, the drug used in this trial)
• People with a history of a primary immune deficiency condition
• People with a history of abnormal bleeding or a bleeding disorder within 6 months before joining the trial
• People with a history of, or signs suggesting, certain blood or bone marrow disorders (myelodysplastic syndrome or acute myeloid leukaemia)
• People who have previously had a bone marrow transplant or a double umbilical cord blood transplant from a donor
• People with an active tuberculosis, hepatitis B, hepatitis C, or HIV infection (certain past or resolved cases of hepatitis B or C may still be eligible — confirm with trial site)
• People currently taking certain medications that are known to strongly or moderately interfere with how the study drug (olaparib) is processed by the body — specific medication lists should be confirmed with the trial site, and a washout period may be required before joining
• People who are unable to swallow tablets or capsules, or who have a digestive condition likely to affect how the study medication is absorbed
• People who, in the opinion of the investigating doctor, would be unable to complete the study or to give meaningful informed consent for medical or psychological reasons
• People who are under legal guardianship or whose ability to give consent is restricted by a court or administrative order
• People with a known allergy to olaparib or any of its ingredients
• People who have taken an unlicensed or experimental treatment within 4 weeks before joining the trial
• People who are currently breastfeeding

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