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Alkylating agents

Various Treatments for Endometrial Cancer (CAN-STAMP Trial)

Phase 2 & 3

Recruiting

Led By Amit Oza, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Local TP53 results must be available for Central review.

Eastern Cooperative Group (ECOG) performance status ≤ 2 (Karnofsky ≥60%).

Must not have

Known HIV-positive patients on antiretroviral therapy or active Hepatitis B or C are ineligible.

Patients with evidence of fistula will be excluded.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is studying how well different treatment regimens work in treating patients with serous or p53 abnormal endometrial cancer.

Who is the study for?

This trial is for women with serous or p53 abnormal endometrial cancer who've had optimal surgery, have a performance status ≤2, and available tissue samples. They must understand the consent form, not have received prior treatment for this cancer, and agree to contraception. Exclusions include previous chemotherapy for endometrial cancer, certain mixed tumors, recent radiotherapy affecting bone marrow, uncontrolled illnesses that affect study compliance, known brain metastases unless stable post-treatment over 1 month, pregnancy, active HIV or Hepatitis B/C on therapy.

What is being tested?

The trial tests if external beam radiation (EBRT) improves disease-free survival compared to vaginal brachytherapy after chemotherapy in early-stage patients. For advanced stages, it examines whether maintenance with Niraparib increases progression-free survival. It's an umbrella two-arm phase II trial where participants are randomly assigned to treatments.

What are the potential side effects?

Potential side effects may include local reactions from radiation like skin irritation or discomfort during brachytherapy application; fatigue; digestive issues; blood disorders from Niraparib such as low platelet counts or anemia; and increased risk of infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My TP53 test results are ready for review.

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I can take care of myself but might not be able to do heavy physical work.

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I have existing tissue samples, or I am willing to undergo a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have HIV, Hepatitis B, or C, or I am not on antiretroviral therapy.

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I do not have a fistula.

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I haven't had major radiotherapy in the last 4 weeks.

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I have been diagnosed with endometrial carcinosarcoma.

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My tumor is a mixed serous type without major p53 gene issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease Free Survival Rate

Secondary study objectives

Overall Survival Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Early Stage Cohort - Arm B1Experimental Treatment2 Interventions

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).

Group II: Early Stage Cohort - Arm AExperimental Treatment1 Intervention

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

Group III: Advanced Stage Cohort Arm D1Experimental Treatment1 Intervention

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

Group IV: Advanced Stage Cohort Arm CActive Control1 Intervention

Observation

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

FDA approved