Comparing treatments for serous or p53 abnormal endometrial cancer
Canadian Multi-arm Multi-stage Randomized Controlled Trial Assessing Front Line and Maintenance Treatment in Serous or p53 Mutant Endometrial Cancer
This study is testing whether different types of radiation therapy can help women with a specific type of endometrial cancer live longer without their cancer coming back, and if adding a maintenance drug can help keep the cancer from progressing.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 267 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04159155 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to evaluate the effectiveness of external beam radiation therapy (EBRT) versus vaginal brachytherapy in improving disease-free survival in women with serous or p53 aberrant endometrial cancer after chemotherapy. Additionally, it aims to assess whether maintenance treatment with niraparib can enhance progression-free survival in patients with advanced-stage disease. The trial incorporates a molecular marker, p53abd, to better tailor treatment strategies for this aggressive cancer subtype. By focusing on personalized treatment approaches, the study seeks to address the high recurrence rates and poor prognosis associated with serous endometrial carcinoma.
Who should consider this trial
Good fit: Ideal candidates include women diagnosed with pure serous endometrial carcinoma or other histotypes with abnormal/mutant-type p53, who are suitable for optimal surgery and have a performance status of ECOG ≤ 2.
Not a fit: Patients with non-serous endometrial cancer histotypes or those who are not suitable for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could lead to improved survival outcomes and personalized treatment options for patients with serous or p53 abnormal endometrial cancer.
How similar studies have performed: Previous studies have explored treatment strategies for endometrial cancer, but this trial's focus on serous carcinoma and the incorporation of molecular markers represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with pure serous endometrial carcinoma will be included. Other histotypes (endometrioid and clear cell) with abnormal/mutant-type p53 is acceptable. * Local TP53 results must be available for Central review. * Patients diagnosed with stage I, II tumors will be enrolled in the early stage cohort. * Patients suitable for an optimal surgery. * Eastern Cooperative Group (ECOG) performance status ≤ 2 (Karnofsky ≥60%). * Life expectancy of greater than 3 months. * Patients must have archival tissue available. If no tissue is available, tumor biopsy will be mandatory. * Ability to understand and willing to sign a written informed consent document. * Within 8 days of the proposed start of treatment, patients must have normal organ and marrow function. * Women of child-bearing potential must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication. Exclusion Criteria: * Any other condition that would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures. * Mixed serous tumors without p53 aberration or with only subclonal p53 aberration * Endometrial carcinosarcoma * Patients being treated with radiotherapy within 4 weeks, or palliative radiotherapy encompassing \>20% of the bone marrow within 1 week of starting study treatment. * Patients who are receiving any other investigational agents. * Participant has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiologic signs of CNS hemorrhage. Note: Participants with asymptomatic brain metastases (i.e. off corticosteroids and anticonvulsants for at least 7 days) are permitted. * Patients with evidence of fistula will be excluded. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study. * Uncontrolled inter-current illness that would limit compliance with study requirements. * Pregnant women are excluded. * Known HIV-positive patients on antiretroviral therapy or active Hepatitis B or C are ineligible. * Patients with a history of other malignancy ≤ 2 years prior to registration, with exceptions.
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Amit Oza, MD — Princess Margaret Cancer Centre
- Study coordinator: Amit Oza, MD
- Email: amit.oza@uhn.ca
- Phone: 416-946-2818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.