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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159155
Recruitment Status : Not yet recruiting
First Posted : November 12, 2019
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Serous Tumor P53 Mutation Drug: Cisplatin Radiation: External Beam Radiation Drug: Carboplatin Drug: Paclitaxel Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Canadian Multi-arm Multi-stage Randomized Controlled Trial Assessing Front Line Treatment in Serous or p53 Mutant Endometrial Cancer
Estimated Study Start Date : February 3, 2020
Estimated Primary Completion Date : February 3, 2025
Estimated Study Completion Date : February 3, 2026

Arm Intervention/treatment
Experimental: Early Stage Cohort - Arm A
Carboplatin, intravenously, once every 3 weeks for 6 cycles Paclitaxel, intravenously, once every 3 weeks for 6 cycles
Drug: Carboplatin
Chemotherapy drug given by vein.

Drug: Paclitaxel
Chemotherapy drug given by vein.

Experimental: Early Stage Cohort - Arm B1
  • 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
Drug: Cisplatin
Chemotherapy drug given by vein.

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

Drug: Carboplatin
Chemotherapy drug given by vein.

Drug: Paclitaxel
Chemotherapy drug given by vein.




Primary Outcome Measures :
  1. Disease Free Survival Rate [ Time Frame: 3 years ]
    Time from random assignment until disease recurrence or death


Secondary Outcome Measures :
  1. Overall Survival Rate [ Time Frame: 5 years ]
    Time from enrollment until death.

  2. Number Adverse Events Experienced [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159155


Contacts
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Contact: Amit Oza, MD 416-946-2818 amit.oza@uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Contact: Amit Oza, MD    416-946-2818    amit.oza@uhn.ca   
Principal Investigator: Amit Oza, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Amit Oza, MD Princess Margaret Cancer Centre
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04159155    
Other Study ID Numbers: 19-6178
CAN-STAMP ( Other Identifier: Princess Margaret Cancer Centre )
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action