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

Primary Purpose

Endometrial Cancer, Serous Tumor, P53 Mutation

Status

Suspended

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Cisplatin

External Beam Radiation

Carboplatin

Paclitaxel

Niraparib

About this trial

This is an interventional treatment trial for Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

Patients who have previously received chemotherapy or hormonal treatment for endometrial cancer.
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 tumours or tumors with subclonal mutant-type p53 staining. Endometrial carcinosarcoma will also be excluded.
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.
Patients with known brain metastases are excluded from participation unless stable for greater than 1 month following definitive treatment.
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 ≤ 3 years prior to registration, with exceptions.

Sites / Locations

Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

No Intervention

Arm Label

Early Stage Cohort - Arm A

Early Stage Cohort - Arm B1

Advanced Stage Cohort Arm C

Advanced Stage Cohort Arm D1

Exploratory Cohort

Arm Description

Carboplatin, intravenously, once every 3 weeks for 6 cycles Paclitaxel, intravenously, once every 3 weeks for 6 cycles

External beam radiotherapy, 5 days per week, for 4-5 weeks Cisplatin intravenously, on the first and fourth week of radiotherapy. Brachytherapy will be given if needed Then Carboplatin, intravenously, once every 3 weeks for 4 cycles Paclitaxel, intravenously, once every 3 weeks for 4 cycles

Carboplatin, intravenously, once every 3 weeks for 6 cycles Paclitaxel, intravenously, once every 3 weeks for 6 cycles

Carboplatin, intravenously, once every 3 weeks for 6 cycles Paclitaxel, intravenously, once every 3 weeks for 6 cycles Then Niraparib daily continuous dosing for 28 day cycles

Observation on Standard of care

Outcomes

Primary Outcome Measures

Disease Free Survival Rate

Time from random assignment until disease recurrence or death

Secondary Outcome Measures

Overall Survival Rate

Time from enrollment until death.

Number Adverse Events Experienced

Full Information

NCT ID

NCT04159155

First Posted

November 7, 2019

Last Updated

June 15, 2023

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT04159155

Brief Title

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

Acronym

CAN-STAMP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Suspended

Why Stopped

Low accrual, protocol amendment in progress , to be re-opened soon.

Study Start Date

November 17, 2020 (Actual)

Primary Completion Date

September 1, 2025 (Anticipated)

Study Completion Date

September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This a phase II and III study whose purpose is to compare how long various treatment regimens can keep the cancer from worsening or coming back in people with serous or p53 abnormal endometrial cancer. The study is divided into three cohorts: Early stage cohort, advanced stage cohort, and exploratory cohort. Each cohort will have different arms to examine different treatment regimens to determine the best regimen for each cohort. The study will enroll participants into the early stage cohort at this time. The early stage cohort will compare the following treatments after standard of care surgery: Adjuvant chemotherapy with carboplatin and paclitaxel alone Adjuvant radiation therapy and chemotherapy with cisplatin, followed by chemotherapy with carboplatin and paclitaxel.

Detailed Description

There is currently no standard or usual treatment for serous or p53 abnormal endometrial cancer after standard surgery. Additional treatment may sometimes be given after the main treatment in hopes of preventing the cancer from worsening or coming back (called adjuvant therapy). It is not fully know whether adjuvant therapy after surgery is useful in early stage endometrial cancer. It is also not known what the best adjuvant therapy after surgery is. The most commonly given adjuvant therapy is chemotherapy with carboplatin and paclitaxel. Sometimes, chemotherapy and radiation therapy may be given. There is not enough information available as to how useful adjuvant therapy is and what the most useful type of treatment is. This study will look at adjuvant chemotherapy alone compared with adjuvant radiation therapy and chemotherapy, after standard of care surgery, in patients with serous or p53 abnormal endometrial cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrial Cancer, Serous Tumor, P53 Mutation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Early Stage Cohort - Arm A

Arm Type

Experimental

Arm Description

Carboplatin, intravenously, once every 3 weeks for 6 cycles Paclitaxel, intravenously, once every 3 weeks for 6 cycles

Arm Title

Early Stage Cohort - Arm B1

Arm Type

Experimental

Arm Description

Arm Title

Advanced Stage Cohort Arm C

Arm Type

Experimental

Arm Description

Carboplatin, intravenously, once every 3 weeks for 6 cycles Paclitaxel, intravenously, once every 3 weeks for 6 cycles

Arm Title

Advanced Stage Cohort Arm D1

Arm Type

Experimental

Arm Description

Carboplatin, intravenously, once every 3 weeks for 6 cycles Paclitaxel, intravenously, once every 3 weeks for 6 cycles Then Niraparib daily continuous dosing for 28 day cycles

Arm Title

Exploratory Cohort

Arm Type

No Intervention

Arm Description

Observation on Standard of care

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Chemotherapy drug given by vein.

Intervention Type

Radiation

Intervention Name(s)

External Beam Radiation

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

Chemotherapy drug given by vein.

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

Chemotherapy drug given by vein.

Intervention Type

Drug

Intervention Name(s)

Niraparib

Intervention Description

Oral drug

Primary Outcome Measure Information:

Title

Disease Free Survival Rate

Description

Time from random assignment until disease recurrence or death

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Overall Survival Rate

Description

Time from enrollment until death.

Time Frame

5 years

Title

Number Adverse Events Experienced

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Patients who have previously received chemotherapy or hormonal treatment for endometrial cancer. 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 tumours or tumors with subclonal mutant-type p53 staining. Endometrial carcinosarcoma will also be excluded. 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. Patients with known brain metastases are excluded from participation unless stable for greater than 1 month following definitive treatment. 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 ≤ 3 years prior to registration, with exceptions.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amit Oza, MD

Organizational Affiliation

Princess Margaret Cancer Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Princess Margaret Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

12. IPD Sharing Statement

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

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