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

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.

Trial Description

Primary Outcome:

• Disease Free Survival Rate

Secondary Outcome:

• Overall Survival Rate
• Number Adverse Events Experienced

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.

View this trial on ClinicalTrials.gov