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Alkylating agents

Early Stage Cohort - Arm A 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%).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

CAN-STAMP Trial 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.Check my eligibility

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.See study design

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.

CAN-STAMP Trial 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.

CAN-STAMP Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease Free Survival Rate

Secondary outcome measures

Number Adverse Events Experienced

Overall Survival Rate

CAN-STAMP 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

External Beam Radiation

2014

Completed Phase 2

~70

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,474 Previous Clinical Trials

484,775 Total Patients Enrolled

6 Trials studying Endometrial Cancer

913 Patients Enrolled for Endometrial Cancer

Amit Oza, MDPrincipal InvestigatorPrincess Margaret Cancer Centre

4 Previous Clinical Trials

619 Total Patients Enrolled

1 Trials studying Endometrial Cancer

44 Patients Enrolled for Endometrial Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still able to enroll in this trial?

"Yes, that is accurate. The most recent information on clinicaltrials.gov suggests that this study is still recruiting patients. This trial was posted on November 17th 2020 with the last edit being made on May 20th 2021. There is a goal to enroll 120 people total from 1 location."

Answered by AI

What is the standard protocol for Carboplatin?

"Carboplatin is not only useful in treating advanced endometrial cancer, but can also be taken to fight melanoma, neoplasm metastasis, lymphoma and non-hodgkin."

Answered by AI

Is Carboplatin a new medication being trialed?

"Currently, 489 phase 3 clinical trials are underway to investigate carboplatin's efficacy. These international studies 1676 active clinical trials and 86429 locations."

Answered by AI

How many individuals are included in this research project?

"From the information available on clinicaltrials.gov, it appears that this study is currently looking for 120 patients from 1 site. The trial was first announced on 11/17/2020 and has since been edited on 5/20/2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "A Study of Various Treatments in Serous or p53 Abnormal Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04159155.

All > Endometrial Cancer