NCT04159155

A Study of Various Treatments in 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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an umbrella, two-arm, multi-stage, phase II trial. The purpose of the trial in the early stage cohort is to determine if EBRT improves disease free survival (defined as the time from random assignment to disease recurrence or death from any cause) compared to vaginal brachytherapy after chemotherapy in women with serous or p53 aberrant endometrial cancer. The purpose of the trial in the advanced stage cohort is to determine if the maintenance with experimental treatment increases progression free survival, defined as the time from random assignment to disease progression or death from any cause.

Detailed description

SC represents a rare and aggressive histologic subtype of endometrial cancer, associated with a poor prognosis. Moreover, there are marked molecular differences between EC and SC, showing the need to separate clinical trials to develop the personalized treatment paradigms that have improved outcomes in other tumor types, such as breast and lung cancer. Given the absence of consensus between pathologists on the diagnosis of SC, this trial will also incorporate a molecular marker, p53abd. Several studies have been done in early stage endometrial cancer including diverse histologies, stages and molecular characteristics. Due to the heterogeneity of the patients, there is a lack of knowledge on the best treatment strategy. Even in cases where disease is apparently confined to the endometrium, the rate of recurrence is high. The role of radiation therapy in the management of this disease, with a high propensity for distant failures, remains elusive. Furthermore, women with endometrial cancer often have multiple comorbidities, needing to optimize the treatment strategies and toxicities. It then results crucial to identify a strategy that is effective and results in limited toxicity. Advanced or recurrent SC has a poor prognosis. There are no maintenance strategies currently approved for endometrial cancer and this is under investigation.

Conditions

• Endometrial Carcinoma
• P53 Mutation
• Serous Carcinoma

Interventions

Type	Name	Description
RADIATION	External Beam Radiation	Radiation therapy given outside the patient to a particular part of the body.
DRUG	Niraparib	Oral drug
RADIATION	Vaginal high-dose rate brachytherapy	Internal radiation to the vagina
OTHER	Observation - no drugs	Observation

Timeline

• Start date: 2020-11-17
• Primary completion: 2025-05-26
• Completion: 2025-05-26
• First posted: 2019-11-12
• Last updated: 2025-08-12

Locations

1 site across 1 country: Canada