PROSPECT: Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IIA rectal cancer, stage IIIA rectal cancer, stage IIIB rectal cancer
Eligibility Criteria
Registration Inclusion Criteria:
- Age ≥ 18 years at diagnosis
- Diagnosis of rectal adenocarcinoma
- Radiologically measurable or clinically evaluable disease as defined in the protocol
- ECOG Performance Status (PS): 0, 1 or 2
- For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined modality neoadjuvant chemoradiation followed by curative intent surgical resection
- Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon
- Primary surgeon is credentialed or is willing to be credentialed in Total Mesorectal Excision (TME), which entails submission of photos of a single TME specimen either before enrolling the first patient or by using the surgeon's 1st accrued case.
Clinical Stage: T2N1, T3N0, T3N1.
- N2 disease is to be estimated as four or more lymph nodes that are ≥ 10 mm.
- Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon, CT or PET/CT scan of the chest/abdomen/pelvis and either a pelvic MRI or an ultrasound (ERUS). If a pelvic MRI is peformed, it is acceptable to perform CT of the chest/abdomen, ommitting CT imaging of the pelvis.
The following laboratory values obtained ≤ 28 days prior to registration:
- Absolute neutrophil count (ANC) ≥ 1500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin > 8.0 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- SGOT (AST) ≤ 3 x ULN
- SGPT (ALT) ≤ 3 x ULN
- Creatinine ≤1.5 x ULN
- Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
- Patient of child-bearing potential is willing to employ adequate contraception
- Provide informed written consent
- Willing to return to enrolling medical site for all study assessments
Registration Exclusion Criteria:
- Clinical T4 tumors
- Primary surgeon indicates need for abdominoperineal (APR) at baseline
- Evidence that the tumor is adherent to or invading the mesorectal fascia on imaging studies such that the surgeon would not be able to perform an R0 resection (one with negative margins)
- Tumor is causing symptomatic bowel obstruction (patients who have had a temporary diverting ostomy are eligible).
- Chemotherapy within 5 years prior to registration. Hormonal therapy is allowable if the disease free interval is ≥ 5 years.
- Any prior pelvic radiation
- Other invasive malignancy ≤ 5 years prior to registration. Exceptions are colonic polyps, non-melanoma skin cancer, ductal carcinoma in situ, bladder carcinoma in situ, or carcinoma-in-situ of the cervix.
Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects.
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Co-morbid illnesses or other concurrent disease which, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Southern Cancer Center PC-Daphne
- Southern Cancer Center PC-Mobile
- Southern Cancer Center PC-Providence
- Southern Cancer Center PC-Springhill
- University of South Alabama Mitchell Cancer Institute
- Anchorage Associates in Radiation Medicine
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Regional Hospital
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Fairbanks Memorial Hospital
- Mayo Clinic Hospital
- Mayo Clinic in Arizona
- University of Arizona Cancer Center-Orange Grove Campus
- University of Arizona Cancer Center-North Campus
- The University of Arizona Medical Center-University Campus
- Yuma Cancer Center
- CHI Saint Vincent Cancer Center Hot Springs
- Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- Highlands Oncology Group-Rogers
- Kaiser Permanente-Anaheim
- Kaiser Permanente-Deer Valley Medical Center
- PCR Oncology
- Sutter Auburn Faith Hospital
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Kaiser Permanente-Baldwin Park
- Kaiser Permanente-Bellflower
- Alta Bates Summit Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills-Peninsula Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- East Bay Radiation Oncology Center
- Eden Hospital Medical Center
- Feather River Cancer Center
- Community Cancer Institute
- University Oncology Associates
- John Muir Medical Center-Concord Campus
- UC Irvine Health Cancer Center-Newport
- Sutter Davis Hospital
- Epic Care-Dublin
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Kaiser Permanente-Fremont
- Palo Alto Medical Foundation-Fremont
- Fresno Cancer Center
- Kaiser Permanente-Fresno
- Marin Cancer Care Inc
- Marin General Hospital
- UC San Diego Moores Cancer Center
- Kaiser Permanente Los Angeles Medical Center
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Cedars Sinai Medical Center
- Contra Costa Regional Medical Center
- Memorial Medical Center
- Kaiser Permanente-Modesto
- El Camino Hospital
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- USC Norris Oncology/Hematology-Newport Beach
- Sutter Cancer Research Consortium
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Hematology and Oncology Associates-Oakland
- Kaiser Permanente-Oakland
- Saint Joseph Hospital - Orange
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Palo Alto Medical Foundation Health Care
- Stanford Cancer Institute Palo Alto
- Keck Medical Center of USC Pasadena
- Valley Medical Oncology Consultants
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Riverside
- Kaiser Permanente-Roseville
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical Center
- Kaiser Permanente Downtown Commons
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- Saint Helena Hospital
- Kaiser Permanente-San Diego Mission
- Kaiser Permanente-San Diego Zion
- Naval Medical Center -San Diego
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- UCSF Medical Center-Mount Zion
- UCSF Medical Center-Mission Bay
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Kaiser Permanente-San Marcos
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Kaiser Permanente-San Rafael
- Kaiser San Rafael-Gallinas
- Kaiser Permanente Medical Center - Santa Clara
- Palo Alto Medical Foundation-Santa Cruz
- Kaiser Permanente-Santa Rosa
- Sutter Pacific Medical Foundation
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Palo Alto Medical Foundation-Sunnyvale
- Northbay Cancer Center
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center/Cancer Center
- Kaiser Permanente-Walnut Creek
- Epic Care Cyberknife Center
- John Muir Medical Center-Walnut Creek
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- University of Colorado Hospital
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- UCHealth Memorial Hospital Central
- Denver Health Medical Center
- National Jewish Health-Main Campus
- The Women's Imaging Center
- Porter Adventist Hospital
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Mercy Medical Center
- Southwest Oncology PC
- Comprehensive Cancer Care and Research Institute of Colorado LLC
- Swedish Medical Center
- Poudre Valley Hospital
- Mountain Blue Cancer Care Center
- National Jewish Health-Western Hematology Oncology
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Good Samaritan Medical Center
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- National Jewish Health-Northern Hematology Oncology
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Yale-New Haven Shoreline Medical Center
- Hartford Hospital
- Smilow Cancer Hospital Care Center at Saint Francis
- Midstate Medical Center
- The Hospital of Central Connecticut
- Smilow Cancer Center/Yale-New Haven Hospital
- Yale University
- Yale-New Haven Hospital North Haven Medical Center
- Norwalk Hospital
- Eastern Connecticut Hematology and Oncology Associates
- Smilow Cancer Hospital Care Center-Trumbull
- Lawrence and Memorial Cancer Center
- Beebe Medical Center
- Christiana Gynecologic Oncology LLC
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Regional Hematology and Oncology PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- Nanticoke Memorial Hospital
- Christiana Care Health System-Wilmington Hospital
- MedStar Georgetown University Hospital
- MedStar Washington Hospital Center
- Florida Hospital Cancer Institute Altamonte
- Mount Sinai Comprehensive Cancer Center at Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
- Holy Cross Hospital
- University of Florida Health Science Center - Gainesville
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
- Integrated Community Oncology Network-Florida Cancer Center Beaches
- Baptist MD Anderson Cancer Center
- Integrated Community Oncology Network-Southside Cancer Center
- Mayo Clinic in Florida
- Baptist Medical Center South
- Jupiter Medical Center
- Florida Hospital Kissimmee
- Lakeland Regional Health Hollis Cancer Center
- The Watson Clinic
- Mount Sinai Medical Center
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- 21st Century Oncology-Orange Park
- Florida Hospital Orlando
- Florida Urology Associates-Orlando
- Florida Hospital East Orlando
- 21st Century Oncology-Palatka
- Memorial Hospital West
- UM Sylvester Comprehensive Cancer Center at Plantation
- Integrated Community Oncology Network-Flager Cancer Center
- Tampa General Hospital
- Florida Hospital Cancer Institute Winter Park
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Emory Saint Joseph's Hospital
- John B Amos Cancer Center
- Atlanta VA Medical Center
- Memorial Health University Medical Center
- Summit Cancer Care-Memorial
- Low Country Cancer Care Associates PC
- Lewis Hall Singletary Oncology Center
- Hawaii Oncology Inc-Pali Momi
- Pali Momi Medical Center
- The Cancer Center of Hawaii-Pali Momi
- Hawaii Cancer Care Inc-POB II
- Hawaii Oncology Inc-POB I
- Island Urology
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Hawaii Oncology Inc-Kuakini
- Kuakini Medical Center
- The Cancer Center of Hawaii-Liliha
- Kaiser Permanente Moanalua Medical Center
- Kapiolani Medical Center for Women and Children
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Mountain States Tumor Institute
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Medical Center
- Walter Knox Memorial Hospital
- Saint Luke's Mountain States Tumor Institute - Fruitland
- Saint Joseph Regional Medical Center
- Idaho Urologic Institute-Meridian
- Saint Luke's Mountain States Tumor Institute - Meridian
- Saint Alphonsus Medical Center-Nampa
- Saint Luke's Mountain States Tumor Institute - Nampa
- Kootenai Cancer Center
- Kootenai Cancer Clinic
- Saint Luke's Mountain States Tumor Institute-Twin Falls
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Mount Sinai Hospital Medical Center
- Hematology and Oncology Associates
- Northwestern University
- John H Stroger Jr Hospital of Cook County
- Rush University Medical Center
- University of Illinois
- Swedish Covenant Hospital
- Presence Resurrection Medical Center
- University of Chicago Comprehensive Cancer Center
- Presence Saint Joseph Hospital-Chicago
- Carle on Vermilion
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Northwestern Medicine Cancer Center Delnor
- NorthShore University HealthSystem-Glenbrook Hospital
- Ingalls Memorial Hospital
- Hematology Oncology Associates of Illinois-Highland Park
- NorthShore University HealthSystem-Highland Park Hospital
- Edward Hines Jr VA Hospital
- Presence Saint Mary's Hospital
- Illinois CancerCare-Kewanee Clinic
- NorthShore Hematology Oncology-Libertyville
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Spector, David MD (UIA Investigator)
- Trinity Medical Center
- Good Samaritan Regional Health Center
- UC Comprehensive Cancer Center at Silver Cross
- Illinois Cancer Specialists-Niles
- University of Chicago Medicine-Orland Park
- Illinois CancerCare-Ottawa Clinic
- Radiation Oncology of Northern Illinois
- Advocate Lutheran General Hospital
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Swedish American Hospital
- SwedishAmerican Regional Cancer Center/ACT
- Hematology Oncology Associates of Illinois - Skokie
- Central Illinois Hematology Oncology Center
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Cancer Care Specialists of Illinois-Swansea
- Southwest Illinois Health Services LLP
- Carle Cancer Center
- The Carle Foundation Hospital
- Northwestern Medicine Cancer Center Warrenville
- Rush-Copley Healthcare Center
- IU Health North Hospital
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Deaconess Clinic Downtown
- Radiation Oncology Associates PC
- Parkview Hospital Randallia
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- Indiana University/Melvin and Bren Simon Cancer Center
- Sidney and Lois Eskenazi Hospital
- Franciscan Health Indianapolis
- Kendrick Colon and Rectal Center-Indianapolis
- Springmill Medical Center
- Community Howard Regional Health
- IU Health La Porte Hospital
- Woodland Cancer Care Center
- Memorial Regional Cancer Center Day Road
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- Franciscan Health Mooresville
- Chancellor Center for Oncology
- Michiana Hematology Oncology PC-Plymouth
- Reid Health
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- South Bend Clinic
- Union Hospital
- Michiana Hematology Oncology PC-Westville
- Constantinou, Costas L MD (UIA Investigator)
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Greater Regional Medical Center
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- Trinity Regional Medical Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Central Care Cancer Center - Garden City
- Saint Catherine Hospital
- Central Care Cancer Center - Great Bend
- Cancer Center of Kansas-Independence
- University of Kansas Cancer Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Kansas Institute of Medicine Cancer and Blood Center
- Minimally Invasive Surgery Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas-Manhattan
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Olathe Medical Center
- Menorah Medical Center
- University of Kansas Cancer Center-Overland Park
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Via Christi Hospital-Pittsburg
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Salina Regional Health Center
- Cotton O'Neil Cancer Center / Stormont Vail Health
- Saint Francis Hospital and Medical Center - Topeka
- Cancer Center of Kansas - Wellington
- University of Kansas Hospital-Westwood Cancer Center
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Wichita
- Via Christi Regional Medical Center
- Wesley Medical Center
- Cancer Center of Kansas - Winfield
- Flaget Memorial Hospital
- Baptist Health Corbin
- Commonwealth Cancer Center-Corbin
- Oncology Hematology Care Inc-Crestview
- Baptist Health Lexington
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- University of Kentucky/Markey Cancer Center
- Saint Joseph London
- Jewish Hospital
- Baptist Health Louisville
- Saints Mary and Elizabeth Hospital
- Jewish Hospital Medical Center Northeast
- Baptist Health Madisonville/Merle Mahr Cancer Center
- Baptist Health Paducah
- Jewish Hospital Medical Center South
- LSU Health Baton Rouge-North Clinic
- Louisiana Hematology Oncology Associates LLC
- Mary Bird Perkins Cancer Center
- Our Lady of the Lake Physicians Group - Medical Oncology
- Louisiana State University Health Science Center
- University Medical Center New Orleans
- Ochsner Medical Center Jefferson
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- University of Maryland/Greenebaum Cancer Center
- Sinai Hospital of Baltimore
- MedStar Union Memorial Hospital
- MedStar Good Samaritan Hospital
- Johns Hopkins University/Sidney Kimmel Cancer Center
- UM Upper Chesapeake Medical Center
- UM Baltimore Washington Medical Center/Tate Cancer Center
- Peninsula Regional Medical Center
- Beverly Hospital
- Massachusetts General Hospital Cancer Center
- Brigham and Women's Hospital
- Boston Medical Center
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- Lahey Hospital and Medical Center
- Addison Gilbert Hospital
- Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
- Berkshire Hematology Oncology PC
- Dana-Farber/Brigham and Women's Cancer Center at South Shore
- Mercy Medical Center
- Baystate Medical Center
- Winchester Hospital
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- IHA Hematology Oncology Consultants-Brighton
- Saint Joseph Mercy Brighton
- Henry Ford Cancer Institute-Downriver
- IHA Hematology Oncology Consultants-Canton
- Saint Joseph Mercy Canton
- Caro Cancer Center
- IHA Hematology Oncology Consultants-Chelsea
- Saint Joseph Mercy Chelsea
- Hematology Oncology Consultants-Clarkston
- Newland Medical Associates-Clarkston
- Henry Ford Macomb Hospital-Clinton Township
- Beaumont Hospital-Dearborn
- Henry Ford Medical Center-Fairlane
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Ascension Saint John Hospital
- Great Lakes Cancer Management Specialists-Doctors Park
- Beaumont Hospital - Farmington Hills
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Lymphoma Clinic of Michigan
- Michigan Breast Specialists-Grosse Pointe Woods
- William Beaumont Hospital-Grosse Point
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Sparrow Hospital
- Hope Cancer Clinic
- Saint Mary Mercy Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of Marlette
- Mid-Michigan Medical Center - Midland
- Monroe Cancer Center
- Lakeland Hospital Niles
- Henry Ford Medical Center-Columbus
- 21st Century Oncology-Pontiac
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy Oakland
- Huron Medical Center PC
- Lake Huron Medical Center
- Great Lakes Cancer Management Specialists-Rochester Hills
- Michigan Cancer Specialists
- Oakland Colon and Rectal Association
- Cancer Care Associates PC
- Comprehensive Medical Center PLLC
- Hematology Oncology Consultants PC
- Oakland Medical Group
- William Beaumont Hospital-Royal Oak
- Saint Mary's of Michigan
- Oncology Hematology Associates of Saginaw Valley PC
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Bhadresh Nayak MD PC-Sterling Heights
- Premier Hematology Oncology Care
- Mitchell Folbe MD PC
- Saint Joseph Health System-Tawas City
- Michigan Institute of Urology-Town Center
- Claudia BR Herke MD PC
- William Beaumont Hospital - Troy
- Hematology Oncology Consultants PC-Troy
- Advanced Breast Care Center PLLC
- Bhadresh Nayak MD PC-Warren
- Great Lakes Cancer Management Specialists-Macomb Professional Building
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland Hospital
- Henry Ford West Bloomfield Hospital
- Saint Mary's Oncology/Hematology Associates of West Branch
- Huron Gastroenterology PC
- IHA Hematology Oncology Consultants-Ann Arbor
- Sanford Joe Lueken Cancer Center
- Fairview Ridges Hospital
- Mercy Hospital
- Fairview-Southdale Hospital
- Unity Hospital
- Hutchinson Area Health Care
- Mayo Clinic Health Systems-Mankato
- Fairview Maple Grove Medical Center
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Minneapolis VA Medical Center
- Health Partners Inc
- Monticello Cancer Center
- New Ulm Medical Center
- North Memorial Medical Health Center
- Mayo Clinic
- Coborn Cancer Center at Saint Cloud Hospital
- Saint Cloud Hospital
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Sanford Cancer Center Worthington
- Fairview Lakes Medical Center
- Gulfport Memorial Hospital
- Central Care Cancer Center - Bolivar
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- Saint Luke's Hospital
- University of Missouri - Ellis Fischel
- Siteman Cancer Center at West County Hospital
- Centerpoint Medical Center LLC
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Saint Luke's Hospital of Kansas City
- Heartland Hematology and Oncology Associates Incorporated
- The University of Kansas Cancer Center-South
- Research Medical Center
- The University of Kansas Cancer Center-North
- The University of Kansas Cancer Center-Lee's Summit
- Saint Luke's East - Lee's Summit
- Liberty Radiation Oncology Center
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Joseph Oncology Inc
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Mercy Hospital South
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Siteman Cancer Center at Christian Hospital
- Mercy Hospital Saint Louis
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- Nebraska Medicine-Bellevue
- CHI Health Saint Francis
- Heartland Hematology and Oncology
- CHI Health Good Samaritan
- Saint Elizabeth Regional Medical Center
- Nebraska Medicine-Village Pointe
- Alegent Health Immanuel Medical Center
- Hematology and Oncology Consultants PC
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- University of Nebraska Medical Center
- Midlands Community Hospital
- Carson Tahoe Regional Medical Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven Hills
- 21st Century Oncology-Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- Desert West Surgery
- University Medical Center of Southern Nevada
- Cancer and Blood Specialists-Shadow
- OptumCare Cancer Care at Oakey
- Radiation Oncology Centers of Nevada Central
- 21st Century Oncology
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Radiation Oncology Centers of Nevada Southeast
- Cancer Therapy and Integrative Medicine
- 21st Century Oncology-Vegas Tenaya
- Ann M Wierman MD LTD
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- OptumCare Cancer Care at MountainView
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- 21st Century Oncology-Fort Apache
- Comprehensive Cancer Centers of Nevada
- OptumCare Cancer Care at Fort Apache
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- University Cancer Center
- Hope Cancer Care of Nevada-Pahrump
- Renown Regional Medical Center
- Alpine Hematology-Oncology
- Saint Mary's Regional Medical Center
- Radiation Oncology Associates
- Cancer Care Specialists - Reno
- Dartmouth Hitchcock Medical Center
- Saint Joseph Hospital
- Memorial Sloan Kettering Basking Ridge
- Cooper Hospital University Medical Center
- Englewood Hospital and Medical Center
- Monmouth Medical Center Southern Campus
- Monmouth Medical Center
- Memorial Sloan Kettering Monmouth
- Morristown Medical Center
- Virtua Memorial
- Saint Peter's University Hospital
- Overlook Hospital
- Virtua Voorhees
- University of New Mexico Cancer Center
- Hematology Oncology Associates of Central New York-Auburn
- Southside Hospital
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center - Moses Campus
- Maimonides Medical Center
- Roswell Park Cancer Institute
- Memorial Sloan Kettering Commack
- Hematology Oncology Associates of Central New York-East Syracuse
- Arnot Ogden Medical Center/Falck Cancer Center
- Glens Falls Hospital
- Memorial Sloan Kettering Westchester
- Huntington Hospital
- Northwell Health/Center for Advanced Medicine
- North Shore University Hospital
- Orange Regional Medical Center
- NYU Winthrop Hospital
- Mount Sinai Union Square
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Mount Sinai West
- Mount Sinai Hospital
- Memorial Sloan Kettering Cancer Center
- Weill Medical College of Cornell University
- Vassar Brothers Medical Center
- University of Rochester
- Memorial Sloan Kettering Rockville Centre
- Memorial Sloan Kettering Sleepy Hollow
- Stony Brook University Medical Center
- Hematology Oncology Associates of Central New York-Onondaga Hill
- AdventHealth Infusion Center Asheville
- UNC Lineberger Comprehensive Cancer Center
- Novant Health Presbyterian Medical Center
- Carolina Surgical Clinic of Charlotte PA
- Oncology Specialists of Charlotte
- Southern Oncology Specialists-Charlotte
- Sampson Radiation Oncology
- Southeastern Medical Oncology Center-Clinton
- AdventHealth Infusion Center Haywood
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Wayne Radiation Oncology
- East Carolina University
- AdventHealth Hendersonville
- Lake Norman Hematology Oncology Specialists-Huntersville
- Southern Oncology Specialists-Huntersville
- Onslow Memorial Hospital
- Southeastern Medical Oncology Center-Jacksonville
- Vidant Oncology-Kenansville
- Vidant Oncology-Kinston
- Matthews Radiation Oncology Center
- Novant Health Cancer Specialists-Matthews
- Lake Norman Hematology Oncology Specialists-Mooresville
- Vidant Oncology-Richlands
- Carolina Oncology Associates PA
- Southeastern Medical Oncology Center-Wilson
- Novant Health Forsyth Medical Center
- Wake Forest University Health Sciences
- Roger Maris Cancer Center
- Sanford Broadway Medical Center
- Sanford Clinic North-Fargo
- Altru Cancer Center
- Summa Akron City Hospital/Cooper Cancer Center
- Summa Barberton Hospital
- UHHS-Chagrin Highlands Medical Center
- Indu and Raj Soin Medical Center
- Strecker Cancer Center-Belpre
- Mercy Medical Center
- Aultman Health Foundation
- Dayton Physicians LLC-Miami Valley South
- Miami Valley Hospital South
- Adena Regional Medical Center
- Oncology Hematology Care Inc-Eden Park
- Oncology Hematology Care Inc-Mercy West
- University of Cincinnati/Barrett Cancer Center
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc - Anderson
- Oncology Hematology Care Inc-Kenwood
- Bethesda North Hospital
- Oncology Hematology Care Inc-Blue Ash
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Case Western Reserve University
- MetroHealth Medical Center
- Ohio State University Comprehensive Cancer Center
- Mount Carmel East Hospital
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital North
- Miami Valley Hospital North
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Oncology Hematology Care Inc-Healthplex
- Armes Family Cancer Center
- Blanchard Valley Hospital
- Orion Cancer Care
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-Atrium
- Dayton Physicians LLC-Wayne
- Wayne Hospital
- Greater Dayton Cancer Center
- First Dayton Cancer Care
- Kettering Medical Center
- Fairfield Medical Center
- Lancaster Radiation Oncology
- OhioHealth Mansfield Hospital
- Marietta Memorial Hospital
- OhioHealth Marion General Hospital
- Dayton Physicians LLC-Signal Point
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Southern Ohio Medical Center
- Dayton Physicians LLC-Wilson
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- ProMedica Flower Hospital
- The Toledo Hospital/Toledo Children's Hospital
- Dayton Physicians LLC-Upper Valley
- Upper Valley Medical Center
- University Pointe
- Saint Ann's Hospital
- UHHS-Westlake Medical Center
- Wright-Patterson Medical Center
- Greene Memorial Hospital
- Genesis Healthcare System Cancer Care Center
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Integris Cancer Institute of Oklahoma
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Oncology and Hematology Care Southeast
- Bay Area Hospital
- Providence Milwaukie Hospital
- Providence Newberg Medical Center
- Saint Alphonsus Medical Center-Ontario
- Providence Willamette Falls Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Kaiser Permanente Northwest
- Saint Charles Health System-Redmond
- Abington Memorial Hospital
- Lehigh Valley Hospital-Cedar Crest
- UPMC-Heritage Valley Health System Beaver
- Lehigh Valley Hospital - Muhlenberg
- Geisinger Medical Center
- Easton Hospital
- The Regional Cancer Center
- Saint Vincent Hospital
- Fox Chase Cancer Center Buckingham
- UPMC Cancer Centers - Arnold Palmer Pavilion
- Penn State Milton S Hershey Medical Center
- Jefferson Hospital
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
- Armstrong Center for Medicine and Health
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- UPMC Cancer Center at UPMC McKeesport
- Forbes Hospital
- UPMC-Coraopolis/Heritage Valley Radiation Oncology
- Drexel University School of Medicine
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Temple University Hospital
- Allegheny General Hospital
- UPMC-Magee Womens Hospital
- UPMC-Presbyterian Hospital
- UPMC-Saint Margaret
- University of Pittsburgh Cancer Institute (UPCI)
- UPMC-Shadyside Hospital
- UPMC Jefferson Regional Radiation Oncology
- UPMC-Passavant Hospital
- UPMC-Saint Clair Hospital Cancer Center
- Pottstown Hospital
- UPMC Cancer Center at UPMC Northwest
- UPMC Uniontown Hospital Radiation Oncology
- UPMC Washington Hospital Radiation Oncology
- Geisinger Wyoming Valley/Henry Cancer Center
- Abington Memorial Hospital-Asplundh Cancer Pavilion
- Greenville Health System Cancer Institute-Laurens
- Greenville Health System Cancer Institute-Easley
- Greenville Health System Cancer Institute-Butternut
- Greenville Health System Cancer Institute-Faris
- Greenville Memorial Hospital
- Greenville Health System Cancer Institute-Eastside
- Greenville Health System Cancer Institute-Greer
- Greenville Health System Cancer Institute-Seneca
- Greenville Health System Cancer Institute-Spartanburg
- Avera Cancer Institute
- Memorial Hospital
- Pulmonary Medicine Center of Chattanooga-Hixson
- Meharry Medical College
- Memorial GYN Plus
- The Don and Sybil Harrington Cancer Center
- Dell Seton Medical Center at The University of Texas
- Saint Joseph Regional Cancer Center
- Baylor University Medical Center
- Lyndon Baines Johnson General Hospital
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Ben Taub General Hospital
- M D Anderson Cancer Center
- Michael E DeBakey VA Medical Center
- The Methodist Hospital System
- Methodist Willowbrook Hospital
- MD Anderson Regional Care Center-Katy
- MD Anderson Regional Care Center-Bay Area
- MD Anderson Regional Care Center-Sugar Land
- Houston Methodist Sugar Land Hospital
- Scott and White Memorial Hospital
- MD Anderson Regional Care Center-The Woodlands
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Riverton Hospital
- Dixie Medical Center Regional Cancer Center
- Utah Cancer Specialists-Salt Lake City
- Huntsman Cancer Institute/University of Utah
- LDS Hospital
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont Medical Center
- University of Vermont College of Medicine
- Norris Cotton Cancer Center-North
- Sentara Martha Jefferson Hospital
- University of Virginia Cancer Center
- Inova Fairfax Hospital
- Hematology Oncology Associates of Fredericksburg Inc
- Sentara Cancer Institute at Sentara CarePlex Hospital
- Centra Lynchburg Hematology-Oncology Clinic Inc
- Bon Secours Saint Francis Medical Center
- Sentara Leigh Hospital
- Sentara Norfolk General Hospital
- Bon Secours Saint Mary's Hospital
- Virginia Commonwealth University/Massey Cancer Center
- VCU Community Memorial Health Center
- Shenandoah Oncology PC
- Providence Regional Cancer System-Aberdeen
- Cancer Care Center at Island Hospital
- MultiCare Auburn Medical Center
- Virginia Mason Bainbridge Island Medical Center
- Overlake Hospital Medical Center
- Swedish Cancer Institute-Eastside Oncology Hematology
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Medical Center-Edmonds
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Virginia Mason Federal Way Medical Center
- Saint Francis Hospital
- Tacoma/Valley Radiation Oncology Centers-Gig Harbor
- MultiCare Gig Harbor Medical Park
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- Northwest Cancer Clinic
- Tri-Cities Cancer Center
- EvergreenHealth Medical Center
- Seattle Cancer Care Alliance at EvergreenHealth
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Virginia Mason Lynnwood Medical Center
- Skagit Valley Hospital Regional Cancer Care Center
- Skagit Valley Hospital
- Jefferson Healthcare
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Peninsula Cancer Center
- MultiCare Good Samaritan Hospital
- Tacoma/Valley Radiation Oncology Centers-Puyallup
- Valley Medical Center
- Virginia Mason Medical Center
- Minor and James Medical PLLC
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- Fred Hutchinson Cancer Research Center
- Seattle Cancer Care Alliance
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- Swedish Medical Center-Cherry Hill
- Seattle Cancer Care Alliance at Northwest Hospital
- University of Washington Medical Center
- PeaceHealth United General Medical Center
- Providence Regional Cancer System-Shelton
- Rockwood Clinic Cancer Treatment Center-Valley
- Cancer Care Northwest - Spokane South
- Rockwood Cancer Treatment Center-DHEC-Downtown
- Spokane Valley Cancer Center-Mayfair
- Cancer Care Northwest-Valley
- Spokane Valley Cancer Center-Mission
- Cancer Care Northwest-North Spokane
- Evergreen Hematology and Oncology PS
- Rockwood North Cancer Treatment Center
- Tacoma/Valley Radiation Oncology Centers-Jackson Hall
- Franciscan Research Center-Northwest Medical Plaza
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- Saint Joseph Medical Center
- Tacoma/Valley Radiation Oncology Centers-Saint Joe's
- PeaceHealth Southwest Medical Center
- Compass Oncology Vancouver
- Providence Saint Mary Regional Cancer Center
- Wenatchee Valley Hospital and Clinics
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Providence Regional Cancer System-Yelm
- United Hospital Center
- Edwards Comprehensive Cancer Center
- WVUH-Berkely Medical Center
- West Virginia University Healthcare
- Camden Clark Medical Center
- Langlade Hospital and Cancer Center
- Aurora Cancer Care-Southern Lakes VLCC
- Marshfield Clinic-Chippewa Center
- HSHS Sacred Heart Hospital
- Marshfield Clinic Cancer Center - Eau Claire
- Marshfield Clinic Cancer Center at Sacred Heart
- Mayo Clinic Health System-Eau Claire Clinic
- Mayo Clinic Health System Eau Claire Hospital-Luther Campus
- Aurora Health Center-Fond du Lac
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Aurora BayCare Medical Center
- Aurora Cancer Care-Kenosha South
- University of Wisconsin Hospital and Clinics
- Aurora Bay Area Medical Group-Marinette
- Bay Area Medical Center
- Marshfield Medical Center-Marshfield
- Marshfield Medical Center
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Froedtert and the Medical College of Wisconsin
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- Cancer Center of Western Wisconsin
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Ascension Saint Mary's Hospital
- Saint Mary's Hospital
- Marshfield Medical Center-Rice Lake
- Vince Lombardi Cancer Clinic-Sheboygan
- Ascension Saint Michael's Hospital
- Saint Michael's Hospital
- Marshfield Clinic Stevens Point Center
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora Cancer Care-Waukesha
- Aspirus Regional Cancer Center
- Marshfield Clinic-Wausau Center
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Diagnostic and Treatment Center
- Marshfield Clinic - Weston Center
- Saint Clare's Hospital
- Aspirus UW Cancer Center
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
- Cheyenne Regional Medical Center-West
- Big Horn Basin Cancer Center
- Billings Clinic-Cody
- Welch Cancer Center
- Tom Baker Cancer Centre
- Cross Cancer Institute
- BCCA-Cancer Centre for the Southern Interior
- BCCA-Vancouver Cancer Centre
- CancerCare Manitoba
- Atlantic Health Sciences Corporation-Saint John Regional Hospital
- London Regional Cancer Program
- Lakeridge Health Oshawa
- Ottawa Hospital and Cancer Center-General Campus
- Niagara Health System-Saint Catharines General
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
- PEI Cancer Treatment Centre-Queen Elizabeth Hospital
- McGill University Department of Oncology
- The Research Institute of the McGill University Health Centre (MUHC)
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
- Shaare Zedek Medical Center
- Kantonsspital Aarau
- University Hospital Basel
- Oncology Institute of Southern Switzerland
- Kantonsspital Graubunden
- University Hospital of Lausanne
- Kantonsspital Winterthur
- Zurich Im Park
- Zurich Hirslanden Klinik
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group 1
Group 2
Patients will receive FOLFOX chemotherapy once every two weeks for 6 cycles total over a period of 12 weeks. After completing FOLFOX chemotherapy, the patient will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor. If the tumor has not decreased in size by at least 20%, the patient will receive 5FUCMT (radiation with chemotherapy). If the tumor has decreased in size by 20%, then the patient will proceed directly to surgery. If all borders of the tumor are normal post surgery, then the patient receives six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal then the patient receives chemoradiation therapy for 5.5 weeks after surgery. After chemoradiation, additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks. Patient observation with follow up evaluations and event monitoring will occur up to 8 years post randomization.
Patients receive 5FUCMT including chemotherapy and radiation therapy for 5.5 weeks. Patients will be given either 5-fluorouracil or capecitabine and radiation therapy. After the chemoradiation therapy is completed, patients will proceed directly to surgery. Post-surgery, patients will receive FOLFOX chemotherapy once every two weeks for 8 cycles total over a period of 16 weeks. Patient observation with follow up evaluations and event monitoring will occur up to 8 years post randomization.