A Study of Various Treatments in Serous or p53 Abnormal Endometrial Cancer (CAN-STAMP)

January 29, 2024 updated by: University Health Network, Toronto

Canadian Multi-arm Multi-stage Randomized Controlled Trial Assessing Front Line and Maintenance Treatment in Serous or p53 Mutant Endometrial Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

267

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Principal Investigator:
          • Amit Oza, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Stage Cohort - Arm A
Pelvic EBRT at 45Gy in 25 fractions, in 1.8Gy fractions daily, 5 days per week
Radiation: External Beam Radiation
Radiation therapy given outside the patient to a particular part of the body.
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).
Radiation: Vaginal high-dose rate brachytherapy
Internal radiation to the vagina
Active Comparator: Advanced Stage Cohort Arm C
Observation
Other: Observation - no drugs
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.
Drug: Niraparib
Oral drug
Other Names:
  • Zejula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival Rate
Time Frame: 3 years
Time from random assignment until disease recurrence or death
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival Rate
Time Frame: 5 years
Time from enrollment until death.
5 years
Number Adverse Events Experienced
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Amit Oza, MD, Princess Margaret Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2020

Primary Completion (Estimated)

September 12, 2025

Study Completion (Estimated)

September 12, 2027

Study Registration Dates

First Submitted

November 7, 2019

First Submitted That Met QC Criteria

November 7, 2019

First Posted (Actual)

November 12, 2019

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAN-STAMP
  • CAPCR 19-6178 (Other Identifier: Princess Margaret Cancer Centre)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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