A Phase II Evaluation of Dose-Painted Intensity-Modulated Radiation Therapy (IMRT) in Combination With 5-Fluorouracil (5-FU) and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal
OBJECTIVES:
Primary
- Determine if dose-painted, intensity-modulated radiation therapy (IMRT), fluorouracil,
and mitomycin C decreases the combined rate of gastrointestinal and genitourinary
adverse events (grade II or greater) by at least 15% in the first 90 days after the
start of treatment in patients with primary invasive carcinoma of the anal canal
compared to patients treated on the radiotherapy, fluorouracil, and mitomycin C arm on
clinical trial RTOG 98-11.
Secondary
- Determine the feasibility of performing IMRT in these patients in a cooperative group
setting.
- Evaluate adverse events experienced by patients treated with this regimen and to
decrease the grade 2 and higher and grade 3 and higher overall adverse event rates by
15% or 20% as compared to the radiotherapy and mitomycin C arm of RTOG 98-11.
- Evaluate the total duration of radiotherapy.
- Evaluate the efficacy of this regimen, in terms of locoregional failure, disease-free
survival, time to colostomy, colostomy-free survival, and overall survival of these
patients.
- Determine clinical complete response at 8 weeks after completion of study treatment.
OUTLINE: This is a multicenter study.
Patients receive mitomycin C IV over 10-30 minutes on days 1 and 29 and fluorouracil IV
continuously over 96 hours on days 1-4 and 29-32. Patients also undergo dose-painted
intensity-modulated radiation therapy once daily, 5 days a week, for 5½ to 6 weeks beginning
on day 1. Treatment continues in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year, every
6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 59 patients will be accrued for this study.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events)
From the start of treatment to 90 days
Yes
Lisa A. Kachnic, MD
Study Chair
Boston Medical Center
United States: Federal Government
CDR0000524057
NCT00423293
December 2006
Name | Location |
---|---|
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Hurley Medical Center | Flint, Michigan 48503 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
St. Mary - Corwin Regional Medical Center | Pueblo, Colorado 81004 |
Methodist Cancer Center at Methodist Hospital | Indianapolis, Indiana 46202 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
Northwest Community Hospital | Arlington Heights, Illinois 60005 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
LDS Hospital | Salt Lake City, Utah 84143 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
Dickinson County Healthcare System | Iron Mountain, Michigan 49801 |
CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
American Fork Hospital | American Fork, Utah 84003 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital | Boca Raton, Florida 33486 |
Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
Piedmont Hospital | Atlanta, Georgia 30309 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
InterCommunity Cancer Center of Western Illinois | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
Kewanee Hospital | Kewanee, Illinois 61443 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
St. Margaret's Hospital | Spring Valley, Illinois 61362 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene, New Hampshire 03431 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
St. Francis Hospital | Federal Way, Washington 98003 |
Cascade Cancer Center at Evergreen Hospital Medical Center | Kirkland, Washington 98034-3013 |
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem, Ohio 44460 |
Cancer Treatment Center | Wooster, Ohio 44691 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
Reid Hospital & Health Care Services | Richmond, Indiana 47374 |
Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland 21921 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Frederick R. and Betty M. Smith Cancer Treatment Center | Sparta, New Jersey 07871 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
St. Luke's Cancer Network at St. Luke's Hospital | Bethlehem, Pennsylvania 18015 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Sandra L. Maxwell Cancer Center | Cedar City, Utah 84720 |
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden, Utah 84403 |
Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton, Virginia 24273 |
Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia 26003 |
Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
Wilmed Radiation Oncology Services | Wilson, North Carolina 27893 |
Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
Solano Radiation Oncology Center | Vacaville, California 95687 |
Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
Baptist Medical Center South | Jascksonville, Florida 32258 |
Florida Oncology Associates | Orange Park, Florida 32073 |
Florida Cancer Center - Palatka | Palatka, Florida 32177 |
Flagler Cancer Center | Saint Augustine, Florida 32086 |
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | Vineland, New Jersey 08360 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
Boston University Cancer Research Center | Boston, Massachusetts 02118 |
Mercy General Hospital | Sacramento, California 95819 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
Bay Medical | Panama City, Florida 32401 |
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis | St Louis, Missouri 63110 |
Cancer Institute of New Jersey at Cooper University Hospital - Camden | Camden, New Jersey 08103 |
Precision Radiotherapy at University Pointe | West Chester, Ohio 45069 |
Frankford Hospital Cancer Center - Torresdale Campus | Philadelphia, Pennsylvania 19114 |
Auburn Radiation Oncology | Auburn, California 95603 |
Radiation Oncology Centers - Cameron Park | Cameron Park, California 95682 |
Radiation Oncology Center - Roseville | Roseville, California 95661 |
Harrison Medical Center | Bremerton, Washington 98310 |
Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters | Saint Peters, Missouri 63376 |
Norris Cotton Cancer Center - North | Saint Johnsbury, Vermont 05819 |
Integrated Community Oncology Network at Southside Cancer Center | Jacksonville, Florida 32207 |
Kansas City Cancer Centers - Southwest | Overland Park, Kansas 66210 |
New Mexico Cancer Center | Albuquerque, New Mexico 87109 |
Central Indiana Cancer Centers - East | Indianapolis, Indiana 46219 |
Willamette Valley Cancer Center - Eugene | Eugene, Oregon 97401 |
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital | Fort Worth, Texas 76104 |
Texas Oncology, PA at Texas Cancer Center - Sherman | Sherman, Texas 75090 |
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land | Sugar Land, Texas 77479 |
Arizona Oncology - Tucson | Tucson, Arizona 85704 |
Kansas City Cancer Centers - South | Kansas City, Missouri 64131 |
Texas Oncology, PA at Texas Cancer Center Dallas Southwest | Dallas, Texas 75237 |
St. Vincent Oncology Center | Indianapolis, Indiana 46260 |