⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Surgery With or Without Chemotherapy and Radiation Therapy in TreatingPatients With Stage I Rectal Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Surgery With or Without Chemotherapy and Radiation Therapy in TreatingPatients With Stage I Rectal Cancer

Official Title: A Phase II Study of Local Excision Alone or Local Excision Plus Adjuvant Chemoradiation Therapy for Small Distal Rectal Cancers

Study ID: NCT00023751

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining surgery with chemotherapy and radiation therapy may kill more tumor cells and prevent recurrence of the cancer. PURPOSE: Phase II trial to study the effectiveness of surgery with or without chemotherapy and radiation therapy in treating patients who have stage I rectal cancer.

Detailed Description: OBJECTIVES: * Determine the overall, disease-free, and colostomy-free survival rates in patients with stage I rectal cancer treated with local excision with or without adjuvant chemotherapy and radiotherapy. * Determine the local, regional, and distant recurrence rates in patients treated with these regimens. * Determine whether loco-regional recurrences after local excision can be successfully salvaged with radical surgery with or without adjuvant therapy for permanent cure in patients treated with these regimens. * Determine whether the analysis of certain histological and molecular markers can help determine prognosis in patients treated with these regimens. * Determine the anorectal, urinary, and sexual function effects in patients treated with these regimens. * Determine the non-functional treatment morbidity and mortality exclusive of anorectal, urinary, and sexual function effects in patients treated with these regimens. * Determine the overall survival of patients with pathology exclusions undergoing local excision. * Determine the efficacy of the current standard in detecting recurrence during follow-up, including office visits, blood tests, and proctoscopy in patients treated with these regimens. OUTLINE: This is a multicenter study. All patients undergo full thickness disc excision. Patients with T3 disease or positive surgical margins after surgery are removed from study. Patients with T1 disease and negative surgical margins after surgery are observed. Patients with T2 disease and negative surgical margins after surgery receive adjuvant therapy. Beginning 42 days after surgery, T2 patients receive leucovorin calcium (CF) IV over 2 hours with fluorouracil (5-FU) IV bolus 1 hour into the infusion once weekly for 6 weeks. Beginning 2 weeks after the completion of chemotherapy, patients receive chemoradiotherapy comprising radiotherapy once daily 5 times a week for 5 weeks and 5-FU IV continuously while receiving radiotherapy. Beginning 2 weeks after the completion of chemoradiotherapy, patients again receive CF IV over 2 hours with 5-FU IV bolus 1 hour into the infusion once weekly for 6 weeks. Chemotherapy repeats after 2 weeks rest for a total of 2 courses. Patients are followed every 3 months for 2 years and then every 6 months for 5 years.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Northeast Alabama Regional Medical Center, Anniston, Alabama, United States

MBCCOP - Gulf Coast, Mobile, Alabama, United States

CCOP - Greater Phoenix, Phoenix, Arizona, United States

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona, United States

Veterans Affairs Medical Center - Tucson, Tucson, Arizona, United States

Arizona Cancer Center, Tucson, Arizona, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock, Arkansas, United States

City of Hope Comprehensive Cancer Center, Duarte, California, United States

Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States

Cedars-Sinai Medical Center, Los Angeles, California, United States

Veterans Affairs Medical Center - West Los Angeles, Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, United States

CCOP - Bay Area Tumor Institute, Oakland, California, United States

Chao Family Comprehensive Cancer Center, Orange, California, United States

University of California Davis Cancer Center, Sacramento, California, United States

Veterans Affairs Medical Center - San Diego, San Diego, California, United States

Veterans Affairs Medical Center - San Francisco, San Francisco, California, United States

CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, United States

David Grant Medical Center, Travis Air Force Base, California, United States

University of Colorado Cancer Center, Denver, Colorado, United States

Veterans Affairs Medical Center - Denver, Denver, Colorado, United States

CCOP - Christiana Care Health Services, Newark, Delaware, United States

Lombardi Cancer Center, Washington, District of Columbia, United States

MBCCOP - Howard University Cancer Center, Washington, District of Columbia, United States

Walter Reed Army Medical Center, Washington, District of Columbia, United States

Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia, United States

Broward General Medical Center, Fort Lauderdale, Florida, United States

Memorial Regional Hospital Comprehensive Cancer Center, Hollywood, Florida, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States

Florida Hospital Cancer Institute, Orlando, Florida, United States

Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center, West Palm Beach, Florida, United States

CCOP - Atlanta Regional, Atlanta, Georgia, United States

Dwight David Eisenhower Army Medical Center, Fort Gordon, Georgia, United States

Cancer Research Center of Hawaii, Honolulu, Hawaii, United States

MBCCOP - Hawaii, Honolulu, Hawaii, United States

Tripler Army Medical Center, Honolulu, Hawaii, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States

MBCCOP - University of Illinois at Chicago, Chicago, Illinois, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, United States

University of Chicago Cancer Research Center, Chicago, Illinois, United States

Louis A. Weiss Memorial Hospital, Chicago, Illinois, United States

CCOP - Central Illinois, Decatur, Illinois, United States

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines, Illinois, United States

Loyola University Medical Center, Maywood, Illinois, United States

West Suburban Center for Cancer Care, River Forest, Illinois, United States

Saint Anthony Medical Center, Rockford, Illinois, United States

Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States

Hematology Oncology Associates of the Quad Cities, Bettendorf, Iowa, United States

Holden Comprehensive Cancer Center, Iowa City, Iowa, United States

University of Kansas Medical Center, Kansas City, Kansas, United States

CCOP - Wichita, Wichita, Kansas, United States

Veterans Affairs Medical Center - Wichita, Wichita, Kansas, United States

Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, United States

Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, United States

Baptist Hospital East - Louisville, Louisville, Kentucky, United States

MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States

Tulane University School of Medicine, New Orleans, Louisiana, United States

Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, United States

Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, United States

Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, United States

Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States

Veterans Affairs Medical Center - Baltimore, Baltimore, Maryland, United States

Brigham and Women's Hospital, Boston, Massachusetts, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Boston Medical Center, Boston, Massachusetts, United States

Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain, Massachusetts, United States

University of Massachusetts Memorial Medical Center - University Campus, Worcester, Massachusetts, United States

Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

Veterans Affairs Medical Center - Detroit, Detroit, Michigan, United States

Henry Ford Hospital, Detroit, Michigan, United States

CCOP - Grand Rapids, Grand Rapids, Michigan, United States

CCOP - Beaumont, Royal Oak, Michigan, United States

Lakeland Medical Center - St. Joseph, Saint Joseph, Michigan, United States

Providence Hospital - Southfield, Southfield, Michigan, United States

Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota, United States

Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi, United States

University of Mississippi Medical Center, Jackson, Mississippi, United States

Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, United States

Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi, United States

Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, United States

Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States

Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, United States

CCOP - Kansas City, Kansas City, Missouri, United States

Barnes-Jewish Hospital, Saint Louis, Missouri, United States

St. Louis University Health Sciences Center, Saint Louis, Missouri, United States

Missouri Baptist Cancer Center, Saint Louis, Missouri, United States

CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States

CCOP - Montana Cancer Consortium, Billings, Montana, United States

University of Nebraska Medical Center, Omaha, Nebraska, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States

Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada, United States

Norris Cotton Cancer Center, Lebanon, New Hampshire, United States

Cooper University Hospital, Camden, New Jersey, United States

Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, United States

MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, United States

Veterans Affairs Medical Center - Albany, Albany, New York, United States

Veterans Affairs Medical Center - Buffalo, Buffalo, New York, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

Elmhurst Hospital Center, Elmhurst, New York, United States

Queens Cancer Center of Queens Hospital, Jamaica, New York, United States

CCOP - North Shore University Hospital, Manhasset, New York, United States

North Shore University Hospital, Manhasset, New York, United States

Weill Medical College of Cornell University, New York, New York, United States

Mount Sinai Medical Center, NY, New York, New York, United States

Herbert Irving Comprehensive Cancer Center, New York, New York, United States

James P. Wilmot Cancer Center, Rochester, New York, United States

State University of New York - Upstate Medical University, Syracuse, New York, United States

Veterans Affairs Medical Center - Syracuse, Syracuse, New York, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States

Veterans Affairs Medical Center - Asheville, Asheville, North Carolina, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States

NorthEast Oncology Associates, Concord, North Carolina, United States

Veterans Affairs Medical Center - Durham, Durham, North Carolina, United States

Duke Comprehensive Cancer Center, Durham, North Carolina, United States

Cape Fear Valley Health System, Fayetteville, North Carolina, United States

Lenoir Memorial Hospital Cancer Center, Kinston, North Carolina, United States

FirstHealth Moore Regional Hospital, Pinehurst, North Carolina, United States

New Hanover Regional Medical Center, Wilmington, North Carolina, United States

CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina, United States

Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States

Veterans Affairs Medical Center - Fargo, Fargo, North Dakota, United States

Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, United States

Barrett Cancer Center, Cincinnati, Ohio, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States

CCOP - Columbus, Columbus, Ohio, United States

Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States

Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States

CCOP - Dayton, Dayton, Ohio, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Veterans Affairs Medical Center - Oklahoma City, Oklahoma City, Oklahoma, United States

Oregon Cancer Institute, Portland, Oregon, United States

Veterans Affairs Medical Center - Portland, Portland, Oregon, United States

CCOP - Columbia River Oncology Program, Portland, Oregon, United States

Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States

Lifespan: The Miriam Hospital, Providence, Rhode Island, United States

Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, United States

Medical University of South Carolina, Charleston, South Carolina, United States

CCOP - Greenville, Greenville, South Carolina, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina, United States

University of Tennessee Cancer Institute, Memphis, Tennessee, United States

Danville Radiation Therapy Center, Memphis, Tennessee, United States

Harrington Cancer Center, Amarillo, Texas, United States

Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, United States

Veterans Affairs Medical Center - Dallas, Dallas, Texas, United States

Brooke Army Medical Center, Fort Sam Houston, Texas, United States

University of Texas Medical Branch, Galveston, Texas, United States

University of Texas - MD Anderson Cancer Center, Houston, Texas, United States

Veterans Affairs Medical Center - Houston, Houston, Texas, United States

Texas Tech University Health Science Center, Lubbock, Texas, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, United States

Veterans Affairs Medical Center - Temple, Temple, Texas, United States

CCOP - Scott and White Hospital, Temple, Texas, United States

Huntsman Cancer Institute, Salt Lake City, Utah, United States

Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, United States

Green Mountain Oncology Group, Bennington, Vermont, United States

Vermont Cancer Center, Burlington, Vermont, United States

Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States

Veterans Affairs Medical Center - White River Junction, White River Junction, Vermont, United States

Martha Jefferson Hospital, Charlottesville, Virginia, United States

Virginia Oncology Associates - Norfolk, Norfolk, Virginia, United States

MBCCOP - Massey Cancer Center, Richmond, Virginia, United States

Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke, Virginia, United States

CCOP - Virginia Mason Research Center, Seattle, Washington, United States

Veterans Affairs Medical Center - Seattle, Seattle, Washington, United States

CCOP - Northwest, Tacoma, Washington, United States

Madigan Army Medical Center, Tacoma, Washington, United States

St. Mary's Medical Center, Huntington, West Virginia, United States

Ministry Medical Group - Northern Region, Rhinelander, Wisconsin, United States

British Columbia Cancer Agency, Vancouver, British Columbia, Canada

University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan, , Puerto Rico

Contact Details

Name: Ronald Bleday, MD

Affiliation: Dana-Farber/Brigham and Women's Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: