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Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:
Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer

Clinical Trial Summary

To learn if chemotherapy given in combination with radiation therapy, followed by maintenance therapy, can help to control endometrial cancer. The safety and effects of this study treatment will also be studied

Clinical Trial Description

Primary Objectives: The primary objective of this study is to describe the safety and toxicity of chemoradiation with concurrent immunotherapy, followed by chemotherapy plus concurrent immunotherapy, followed by immunotherapy maintenence in patients with stage IIIC endometrial cancer. Secondary Objectives: The secondary objectives are listed below. - To estimate progression free survival - To describe the time to recurence and the recurrence patterns including extent and location (i.e. isolated versus multi-focal, pelvic versus distant) - To estimate disease specific survival and overall survival Exploratory: - To determine if the presence of deficient mismatch repair (dMMR) or microsatellite instability correlates with progression free survival, disease free survival and 5-year overall survival - To assess patient reported outcomes (PROs) during the course of treatment and follow up ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05819892
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Pamela Soliman, MD
Phone 713-745-2352
Email psoliman@mdanderson.org
Status Recruiting
Phase Phase 1
Start date July 17, 2023
Completion date March 1, 2028
View Details
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