Spots Global Cancer Trial Database for Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management
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Trial Identification
Brief Title: Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management
Official Title: A Phase II Multicenter Randomized Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management
Study ID: NCT02008656
Conditions
Study Description
Brief Summary: The study is designed to test the hypothesis that patients with Locally advanced rectal cancer ( LARC) treated with Total neoadjuvant therapy (TNT) and Total mesorectal excision (TME) or Non-operative management (NOM) will have an improved 3-year disease-free survival (DFS) compared to patients with similar tumors treated with Chemoradiation therapy (CRT), Total mesorectal excision (TME) and Adjuvant chemotherapy (ACT).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, Irvine, Irvine, California, United States
St. Joseph Hospital, Orange, California, United States
University of California San Francisco, San Francisco, California, United States
John Muir Health, Walnut Creek, California, United States
University of Colorado, Aurora, Colorado, United States
Washington Hospital Center, Washington, District of Columbia, United States
University Of South Florida, Tampa, Florida, United States
Cleveland Clinic Florida, Weston, Florida, United States
University of Chicago, Chicago, Illinois, United States
University of Michigan, Northville, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
CHI Heath Bergan Mercy, Omaha, Nebraska, United States
Colon and Rectal Surgery, Incorporated, Omaha, Nebraska, United States
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
Memorial Sloan Kettering Commack, Commack, New York, United States
Memorial Sloan Kettering Westchester, Harrison, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Memorial Sloan Kettering Cancer Center at Phelps, Sleepy Hollow, New York, United States
Memorial Sloan Kettering Nassau, Uniondale, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
University of Vermont Medical Center, Burlington, Vermont, United States
University of Virginia, Charlottesville, Virginia, United States
University of Washington School of Medicine, Seattle, Washington, United States
Contact Details
Name: Julio Garcia Aguilar, MD, PhD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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