A Study of Various Treatments in Serous or p53 Abnormal Endometrial Cancer

• Status: Recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

This a phase II and III study whose purpose is to compare how long various treatment regimens can keep the cancer from worsening or coming back in people with serous or p53 abnormal endometrial cancer.

The study is divided into three cohorts: Early stage cohort, advanced stage cohort, and exploratory cohort. Each cohort will have different arms to examine different treatment regimens to determine the best regimen for each cohort.

The study will enroll participants into the early stage cohort at this time. The early stage cohort will compare the following treatments after standard of care surgery:

• Adjuvant chemotherapy with carboplatin and paclitaxel alone

• Adjuvant radiation therapy and chemotherapy with cisplatin, followed by chemotherapy with carboplatin and paclitaxel.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Niraparib; Paclitaxel

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:

• Patients who have previously received chemotherapy or hormonal treatment for endometrial cancer.

• 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 tumours or tumors with subclonal mutant-type p53 staining. Endometrial carcinosarcoma will also be excluded.

• 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.

• Patients with known brain metastases are excluded from participation unless stable for greater than 1 month following definitive treatment.

• 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 ≤ 3 years prior to registration, with exceptions.