Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas
A Phase III Study of Pre and Post Chemoradiation 5-FU vs. Pre and Post Chemoradiation Gemcitabine for Postoperative Adjuvant Treatment of Resected Pancreatic Adenocarcinoma
4 other identifiers
interventional
518
2 countries
107
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 radiation therapy with chemotherapy may kill more tumor cells. It is not yet known which treatment regimen is most effective for pancreatic cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and gemcitabine plus radiation therapy in treating patients with cancer of the pancreas who have undergone surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pancreatic-cancer
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedNovember 19, 2013
November 1, 2013
7.3 years
November 1, 1999
November 18, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Radiation Therapy Oncology Grouplead
- National Cancer Institute (NCI)collaborator
- Eastern Cooperative Oncology Groupcollaborator
- SWOG Cancer Research Networkcollaborator
Study Sites (107)
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300, United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688, United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012, United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804, United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553, United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305, United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403, United States
David Grant Medical Center
Travis Air Force Base, California, 94535, United States
University of Colorado Cancer Center
Denver, Colorado, 80010, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220, United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813-2424, United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612, United States
CCOP - Central Illinois
Decatur, Illinois, 62526, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141, United States
Loyola University Medical Center
Maywood, Illinois, 60153-5500, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7353, United States
CCOP - Wichita
Wichita, Kansas, 67214-3882, United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084, United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112, United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112, United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932, United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769, United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975, United States
CCOP - Duluth
Duluth, Minnesota, 55805, United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505, United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, 39534-2576, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128, United States
CCOP - Kansas City
Kansas City, Missouri, 64131, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807, United States
St. Louis University Health Sciences Center
St Louis, Missouri, 63110, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138, United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131, United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208, United States
Western New York Urology Associates
Buffalo, New York, 14220, United States
St. Vincents Comprehensive Cancer Center
New York, New York, 10011, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288, United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0501, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001, United States
CCOP - Columbus
Columbus, Ohio, 43206, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428, United States
CCOP - Dayton
Kettering, Ohio, 45429, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104, United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207, United States
CCOP - Columbia River Program
Portland, Oregon, 97225, United States
Oregon Cancer Institute
Portland, Oregon, 97239, United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799, United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721, United States
CCOP - Greenville
Greenville, South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4095, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030, United States
Texas Tech University Health Science Center
Lubbock, Texas, 79415, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7845, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284, United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504, United States
CCOP - Scott and White Hospital
Temple, Texas, 76508, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148, United States
Eastern Virginia Medical School
Norfolk, Virginia, 23510-1115, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108, United States
CCOP - Northwest
Tacoma, Washington, 98405-0986, United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000, United States
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6, Canada
Related Publications (19)
Abrams RA, Winter KA, Regine WF, Safran H, Hoffman JP, Lustig R, Konski AA, Benson AB, Macdonald JS, Rich TA, Willett CG. Failure to adhere to protocol specified radiation therapy guidelines was associated with decreased survival in RTOG 9704--a phase III trial of adjuvant chemotherapy and chemoradiotherapy for patients with resected adenocarcinoma of the pancreas. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):809-16. doi: 10.1016/j.ijrobp.2010.11.039. Epub 2011 Feb 1.
PMID: 21277694RESULTBerger AC, Winter K, Hoffman JP, Regine WF, Abrams RA, Safran H, Freedman GM, Benson AB 3rd, Macdonald J, Willett CG. Five year results of US intergroup/RTOG 9704 with postoperative CA 19-9 </=90 U/mL and comparison to the CONKO-001 trial. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):e291-7. doi: 10.1016/j.ijrobp.2012.04.035. Epub 2012 Jun 9.
PMID: 22682806RESULTFarrell JJ, Bae K, Wong J, Guha C, Dicker AP, Elsaleh H. Cytidine deaminase single-nucleotide polymorphism is predictive of toxicity from gemcitabine in patients with pancreatic cancer: RTOG 9704. Pharmacogenomics J. 2012 Oct;12(5):395-403. doi: 10.1038/tpj.2011.22. Epub 2011 May 31.
PMID: 21625252RESULTRegine WF, Winter KA, Abrams R, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Rich TA, Willett CG. Fluorouracil-based chemoradiation with either gemcitabine or fluorouracil chemotherapy after resection of pancreatic adenocarcinoma: 5-year analysis of the U.S. Intergroup/RTOG 9704 phase III trial. Ann Surg Oncol. 2011 May;18(5):1319-26. doi: 10.1245/s10434-011-1630-6. Epub 2011 Mar 10.
PMID: 21499862RESULTShowalter TN, Winter KA, Berger AC, Regine WF, Abrams RA, Safran H, Hoffman JP, Benson AB, MacDonald JS, Willett CG. The influence of total nodes examined, number of positive nodes, and lymph node ratio on survival after surgical resection and adjuvant chemoradiation for pancreatic cancer: a secondary analysis of RTOG 9704. Int J Radiat Oncol Biol Phys. 2011 Dec 1;81(5):1328-35. doi: 10.1016/j.ijrobp.2010.07.1993. Epub 2010 Oct 8.
PMID: 20934270RESULTTempero MA, Winter KA, Kim GE, et al.: S100A2 as a prognostic marker in patients receiving adjuvant therapy for pancreatic cancer (PC): A secondary analysis of RTOG 9704. [Abstract] J Clin Oncol 29 (Suppl 15): A-4118, 2011.
RESULTFarrell J, Bae K, Guha C, et al.: Correlation of cytidine deaminase single nucleotide polymorphism and toxicity from gemcitabine in patients with pancreatic cancer from RTOG 9704. [Abstract] American Society of Clinical Oncology 2009 Gastrointestinal Cancers Symposium, 15-17 January 2009, San Francisco, CA. A-115, 2009.
RESULTFarrell JJ, Elsaleh H, Garcia M, Lai R, Ammar A, Regine WF, Abrams R, Benson AB, Macdonald J, Cass CE, Dicker AP, Mackey JR. Human equilibrative nucleoside transporter 1 levels predict response to gemcitabine in patients with pancreatic cancer. Gastroenterology. 2009 Jan;136(1):187-95. doi: 10.1053/j.gastro.2008.09.067. Epub 2008 Oct 7.
PMID: 18992248RESULTPiperdi B, Ng S, Piperdi M, et al.: Single institutional experience with oral capecitabine (Cap) in adjuvant therapy for pancreatic cancer: Gemcitabine (G) followed by Cap/RT followed by G. [Abstract] American Society of Clinical Oncology 2009 Gastrointestinal Cancers Symposium, 15-17 January 2009, San Francisco, CA. A-229, 2009.
RESULTBerger AC, Garcia M Jr, Hoffman JP, Regine WF, Abrams RA, Safran H, Konski A, Benson AB 3rd, MacDonald J, Willett CG. Postresection CA 19-9 predicts overall survival in patients with pancreatic cancer treated with adjuvant chemoradiation: a prospective validation by RTOG 9704. J Clin Oncol. 2008 Dec 20;26(36):5918-22. doi: 10.1200/JCO.2008.18.6288. Epub 2008 Nov 24.
PMID: 19029412RESULTRegine WF, Winter KA, Abrams RA, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Kudrimoti MR, Fromm ML, Haddock MG, Schaefer P, Willett CG, Rich TA. Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial. JAMA. 2008 Mar 5;299(9):1019-26. doi: 10.1001/jama.299.9.1019.
PMID: 18319412RESULTAbrams RA, Winter KA, Regine WF, et al.: Correlation of RTOG 9704 (adjuvant therapy (rx) of pancreatic adenocarcinoma (pan ca)) radiation therapy quality assurance scores (RTQASc) with survival (S). [Abstract] J Clin Oncol 25 (Suppl 18): A-4523, 2007.
RESULTBerger AC, Winter K, Hoffman J, et al.: Post-resection CA 19-9 predicts overall survival (OS) in patients treated with adjuvant chemoradiation: a secondary endpoint of RTOG 9704. [Abstract] J Clin Oncol 25 (Suppl 18): A-4522, 2007.
RESULTRegine WF, Garcia M, Berger AC, et al.: Post-resectional CA 19-9 values >90 are associated with significantly worse survival in patients with pancreatic carcinoma treated with adjuvant therapy on RTOG 9704: implications for current and future trials. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-137, S78, 2007.
RESULTAbrams RA, Winter KA, Regine WF, et al.: RTOG 9704: radiotherapy quality assurance (QA) review and survival. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-39, S22, 2006.
RESULTRegine WF, Winter KA, Abrams R, et al.: A phase III intergroup trial (RTOG 97-04) of adjuvant pre and post chemoradiation (CRT) 5-FU vs. gemcitabine (G) for resected pancreatic adenocarcinoma. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-42, S23-4, 2006.
RESULTRegine WF, Winter KW, Abrams R, et al.: RTOG 9704 a phase III study of adjuvant pre and post chemoradiation (CRT) 5-FU vs. gemcitabine (G) for resected pancreatic adenocarcinoma. [Abstract] J Clin Oncol 24 (Suppl 18): A-4007, 180s, 2006.
RESULTReyngold M, Winter KA, Regine WF, Abrams RA, Safran H, Hoffman JP, Mowat RB, Hayes JP, Kessel IL, DiPetrillo T, Narayan S, Chen Y, Ben-Josef E, Delouya G, Suh JH, Meyer J, Haddock MG, Feldman M, Gaur R, Yost K, Peterson RA, Sherr DL, Moughan J, Crane CH. Marital Status and Overall Survival in Patients with Resectable Pancreatic Cancer: Results of an Ancillary Analysis of NRG Oncology/RTOG 9704. Oncologist. 2020 Mar;25(3):e477-e483. doi: 10.1634/theoncologist.2019-0562. Epub 2019 Dec 16.
PMID: 32162826DERIVEDLawrence YR, Moughan J, Magliocco AM, Klimowicz AC, Regine WF, Mowat RB, DiPetrillo TA, Small W Jr, Simko JP, Golan T, Winter KA, Guha C, Crane CH, Dicker AP. Expression of the DNA repair gene MLH1 correlates with survival in patients who have resected pancreatic cancer and have received adjuvant chemoradiation: NRG Oncology RTOG Study 9704. Cancer. 2018 Feb 1;124(3):491-498. doi: 10.1002/cncr.31058. Epub 2017 Oct 20.
PMID: 29053185DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
William F. Regine, MD
Lucille P. Markey Cancer Center at University of Kentucky
- STUDY CHAIR
Al B. Benson, MD, FACP
Robert H. Lurie Cancer Center
- STUDY CHAIR
John S. MacDonald, MD
Beth Israel Comprehensive Cancer Center - West Side Campus
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
July 1, 1998
Primary Completion
October 1, 2005
Last Updated
November 19, 2013
Record last verified: 2013-11