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

NCT04159155 | Terminated Phase 2 DMC

• 2 other identifiers: CAN-STAMPCAPCR 19-6178
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival Rate

  Time from random assignment until disease recurrence or death

  3 years

Secondary Outcomes (2)

• Overall Survival Rate

  5 years

• Number Adverse Events Experienced

  5 years

Study Arms (4)

Early Stage Cohort - Arm A

EXPERIMENTAL

Pelvic EBRT at 45Gy in 25 fractions, in 1.8Gy fractions daily, 5 days per week

Radiation: External Beam Radiation

Early Stage Cohort - Arm B1

EXPERIMENTAL

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).

Radiation: Vaginal high-dose rate brachytherapy

Advanced Stage Cohort Arm C

ACTIVE COMPARATOR

Observation

Other: Observation - no drugs

Advanced Stage Cohort Arm D1

EXPERIMENTAL

Investigational agent (niraparib), orally, at a dose of 200 mg, or 300 mg, once daily, based on baseline platelet count and weight.

Drug: Niraparib

Interventions

External Beam Radiation RADIATION

Radiation therapy given outside the patient to a particular part of the body.

Early Stage Cohort - Arm A

Niraparib DRUG

Oral drug

Also known as: Zejula

Advanced Stage Cohort Arm D1

Vaginal high-dose rate brachytherapy RADIATION

Internal radiation to the vagina

Early Stage Cohort - Arm B1

Observation - no drugs OTHER

Observation

Advanced Stage Cohort Arm C

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Cystadenocarcinoma, Serous

Interventions

niraparib

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Cystadenocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Cystic, Mucinous, and Serous

Study Officials

• Amit Oza, MD

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 12, 2019
• Study Start: November 17, 2020
• Primary Completion: May 26, 2025
• Study Completion: May 26, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)