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

NCT04159155 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-08-12

No results posted yet for this study

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.

Conditions

  • Endometrial Carcinoma
  • P53 Mutation
  • Serous Carcinoma

Interventions

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

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Amit Oza, MD · Princess Margaret Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2025-05-26
Completion
2025-05-26

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04159155 on ClinicalTrials.gov