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
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.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Disease Free Survival Rate
Secondary Outcome
Overall Survival Rate
Condition
Endometrial Cancer
Intervention
Cisplatin
Study Arms / Comparison Groups
Early Stage Cohort - Arm A
Description: Carboplatin, intravenously, once every 3 weeks for 6 cycles Paclitaxel, intravenously, once every 3 weeks for 6 cycles
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
120
Start Date
November 17, 2020
Completion Date
September 1, 2026
Primary Completion Date
September 1, 2025
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Amit Oza, MD, 416-946-2818, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT04159155
Organization ID
CAN-STAMP
Secondary IDs
CAPCR 19-6178
Responsible Party
Sponsor
Study Sponsor
University Health Network, Toronto
Study Sponsor
Amit Oza, MD, Principal Investigator, Princess Margaret Cancer Centre
Verification Date
April 2021