Clinical Trials /

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

NCT04159155

Description:

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.

Related Conditions:
  • Endometrial Carcinoma
  • Endometrial Serous Adenocarcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Various Treatments in Serous or p53 Abnormal Endometrial Cancer
  • Official Title: Canadian Multi-arm Multi-stage Randomized Controlled Trial Assessing Front Line Treatment in Serous or p53 Mutant Endometrial Cancer

Clinical Trial IDs

  • ORG STUDY ID: CAN-STAMP
  • NCT ID: NCT04159155

Conditions

  • Endometrial Cancer
  • Serous Tumor
  • P53 Mutation

Interventions

DrugSynonymsArms
CisplatinEarly Stage Cohort - Arm B1
CarboplatinEarly Stage Cohort - Arm A
PaclitaxelEarly Stage Cohort - Arm A

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Early Stage Cohort - Arm AExperimentalCarboplatin, intravenously, once every 3 weeks for 6 cycles Paclitaxel, intravenously, once every 3 weeks for 6 cycles
  • Carboplatin
  • Paclitaxel
Early Stage Cohort - Arm B1ExperimentalExternal 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
  • Cisplatin
  • Carboplatin
  • Paclitaxel

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

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

Details

Phase:Phase 2/Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University Health Network, Toronto

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