Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer
Start Date
6/26/2024
Completion Date
6/30/2030
Summary
This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?
Detailed Description
This study is being done to find out if this approach is better or worse than the usual approach for early rectal cancer. The usual approach is defined as care most people get for early rectal cancer. The usual approach for patients who are not in a study is surgery to remove the rectum or treatment with chemotherapy and radiation therapy, followed by surgery. There are several chemotherapy drugs approved by Health Canada that are commonly used with radiation therapy. For patients who get the usual approach for this cancer, about 90 out of 100 are free of cancer after 5 years. If a patient decides to take part in this study, they will either get a combination of chemotherapy drugs called FOLFOX or CAPOX for up to 12 weeks or will get chemotherapy with radiation therapy for up to 6 weeks. After finishing treatment, and even if treatment is stopped early, the study doctor will watch for side effects and determine which type of surgery would be best. After surgery, patients will be asked to come in every 4 months for 2 years, then every 6 months for an additional year. Then will be checked every year for 2 years. This means seeing the study doctor for up to 5 years after surgery. Patients may be seen more often if your study doctor thinks it is necessary.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Leucovorin
Oxaliplatin
Fluoruracil
Capecitabine
Radiation
Conditions
Locations
Cancer Center at Saint Joseph's
Phoenix, Arizona 85004
United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612
United States
Los Angeles General Medical Center
Los Angeles, California 90033
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California 93444
United States
Beebe South Coastal Health Campus
Millville, Delaware 19967
United States
Helen F Graham Cancer Center
Newark, Delaware 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
United States
Beebe Health Campus
Rehoboth Beach, Delaware 19971
United States
Orlando Health Cancer Institute
Orlando, Florida 32806
United States
Emory University Hospital Midtown
Atlanta, Georgia 30308
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
United States
Rush-Copley Medical Center
Aurora, Illinois 60504
United States
Northwestern University
Chicago, Illinois 60611
United States
Carle at The Riverfront
Danville, Illinois 61832
United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
United States
Carle Physician Group-Effingham
Effingham, Illinois 62401
United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United States
Carle Cancer Center
Urbana, Illinois 61801
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
United States
Northwest Cancer Center - Crown Point
Crown Point, Indiana 46307
United States
Northwest Oncology LLC
Dyer, Indiana 46311
United States
Northwest Cancer Center - Hobart
Hobart, Indiana 46342
United States
Saint Mary Medical Center
Hobart, Indiana 46342
United States
The Community Hospital
Munster, Indiana 46321
United States
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana 46383
United States
Ochsner Hematology Oncology North Shore - Covington (West Region)
Covington, Louisiana 70433
United States
University Medical Center New Orleans
New Orleans, Louisiana 70112
United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
United States
Beverly Hospital
Beverly, Massachusetts 01915
United States
Lahey Clinic
Burlington, Massachusetts 01805
United States
Addison Gilbert Hospital
Gloucester, Massachusetts 01930
United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan 48183
United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan 48126
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan 49503
United States
Allegiance Health
Jackson, Michigan 49201
United States
West Michigan Cancer Center
Kalamazoo, Michigan 49007
United States
Henry Ford Medical Center-Columbus
Novi, Michigan 48377
United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
United States
Henry Ford Wyandotte Hospital
Wyandotte, Michigan 48192
United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
United States
Mercy Hospital Saint Louis
St Louis, Missouri 63141
United States
Renown Regional Medical Center
Reno, Nevada 89502
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Memorial Sloan Kettering Commack
Commack, New York 11725
United States
Memorial Sloan Kettering Westchester
Harrison, New York 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
University of Rochester
Rochester, New York 14642
United States
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
United States
Wilmot Cancer Institute at Webster
Webster, New York 14580
United States
East Carolina University
Greenville, North Carolina 27834
United States
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
United States
Sanford Broadway Medical Center
Fargo, North Dakota 58122
United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
United States
Miami Valley Hospital South
Centerville, Ohio 45459
United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Miami Valley Hospital
Dayton, Ohio 45409
United States
Premier Blood and Cancer Center
Dayton, Ohio 45409
United States
Miami Valley Hospital North
Dayton, Ohio 45415
United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
United States
Upper Valley Medical Center
Troy, Ohio 45373
United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
United States
Clackamas Radiation Oncology Center
Clackamas, Oregon 97015
United States
Legacy Mount Hood Medical Center
Gresham, Oregon 97030
United States
Providence Newberg Medical Center
Newberg, Oregon 97132
United States
Providence Willamette Falls Medical Center
Oregon City, Oregon 97045
United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon 97210
United States
Providence Portland Medical Center
Portland, Oregon 97213
United States
Providence Saint Vincent Medical Center
Portland, Oregon 97225
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
Legacy Meridian Park Hospital
Tualatin, Oregon 97062
United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
United States
The West Clinic - Wolf River
Germantown, Tennessee 38138
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
United States
UT MD Anderson Cancer Center
Houston, Texas 77030
United States
Scott and White Memorial Hospital
Temple, Texas 76508
United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont 05819
United States
FHCC Overlake
Bellevue, Washington 98004
United States
FHCC at EvergreenHealth
Kirkland, Washington 98034
United States
Virginia Mason Medical Center
Seattle, Washington 98101
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
FHCC at Northwest Hospital
Seattle, Washington 98133
United States
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington 98684
United States
Legacy Salmon Creek Hospital
Vancouver, Washington 98686
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin 54548
United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
United States
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
United States
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia V5Z 4E6
Canada
CancerCare Manitoba
Winnipeg, Manitoba R3E 0V9
Canada
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador A1B 3V6
Canada
London Regional Cancer Program
London, Ontario N6A 4L6
Canada
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario K1H 8L6
Canada
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
Montreal, Quebec H1T 2M4
Canada
Allan Blair Cancer Centre
Regina, Saskatchewan S4T 7T1
Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan S7N 4H4
Canada