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

Sponsor
University Health Network, Toronto
Study ID
NCT04159155
Phase
PHASE2/PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 17, 2020
Status verified
Aug 2025
Primary completion
May 26, 2025
Completion
May 26, 2025

Study Design

Enrollment
11 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Early Stage Cohort - Arm A
    Pelvic EBRT at 45Gy in 25 fractions, in 1.8Gy fractions daily, 5 days per week
  • Experimental: Early Stage Cohort - Arm B1
    Vaginal high-dose rate brachytherapy 21 Gy in 3 fractions, prescribed to 5mm (i.e. 100% isodose at 5mm) from the cylinder/applicator surface and top along the upper third to half of the vagina (minimum 3cm, maximum 4cm).
  • Active Comparator: Advanced Stage Cohort Arm C
    Observation
  • Experimental: Advanced Stage Cohort Arm D1
    Investigational agent (niraparib), orally, at a dose of 200 mg, or 300 mg, once daily, based on baseline platelet count and weight.

Primary Outcome Measure

Disease Free Survival Rate [ Time Frame: 3 years ]

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