Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer
- Conditions
- Anal Cancer
- Interventions
- Registration Number
- NCT00423293
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with 5-fluorouracil (5-FU) and mitomycin C may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving intensity-modulated radiation therapy together with fluorouracil and mitomycin C works in treating patients with invasive anal cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 5-FU + Mitomycin + IMRT fluorouracil 5-FU + Mitomycin + IMRT 5-FU + Mitomycin + IMRT Intensity-modulated radiation therapy 5-FU + Mitomycin + IMRT 5-FU + Mitomycin + IMRT mitomycin C 5-FU + Mitomycin + IMRT
- Primary Outcome Measures
Name Time Method Percentage of Subjects With Acute 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 Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Acute toxicities occur within 90 days of the start of treatment.
- Secondary Outcome Measures
Name Time Method Five-year Rate of Overall Survival From registration to 5 years Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Number of Patients With Major Radiation Planning Deviations Planning occurred prior to radiation therapy Deviations in intensity-modulated radiation therapy technique (IMRT) planning were determined by central review by the radiation oncology co-chairs of the study.
Percentage of Subjects With Acute Adverse Events (AE) From the start of treatment to 90 days Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Acute toxicities occur within 90 days of the start of treatment.
Percentage of Subjects With Late Adverse Events (AE) From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 9.2 years. Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Late toxicities occur greater than 90 days from the start of treatment.
Clinical Complete Response Rate 8 and 12 weeks after treatment completion (corresponding to 14 and 18 weeks from registration) A complete clinical response was defined as complete resolution of all palpable tumor determined by digital rectal exam and proctosigmoidoscopy supplemented with pelvic axial imaging.
Five-year Rate of Disease-free Survival From registration to 5 years Disease-free survival time is defined as time from registration to the date of local-regional failure, the appearance of distant metastases, the appearance of a second primary failure, or date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact. Local failure is defined as any measurable disease after 12 weeks from the completion of chemoradiation therapy. Local failure is defined as: a) For patients with no disease in pelvic and/or groin nodes, the appearance of disease in pelvic or groin nodes; b) For patients with disease in pelvic and/or groin nodes at study entry, nodal recurrence following clearance or persistent nodal disease for more than 12 weeks after completion of treatment.
Five-Year Rate of Colostomy-free Survival From registration to 5 years Colostomy-free survival time is defined as time from registration to date of colostomy or abdominoperineal (A-P) resection, or date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact.
Duration of Radiotherapy Treatment From start to end of radiation therapy (6 weeks) Number of days from radiotherapy treatment start to radiotherapy treatment end
Five-Year Cumulative Incidence Rate of Local-regional Failure From registration to 5 years Local-regional failure time is defined as time from registration to date of failure and is estimated by the cumulative incidence method. Patients last known to be alive without failure are censored at the date of last contact. Local-regional failure is defined as a local or regional failure. Local failure is defined as any measurable disease after 12 weeks from the completion of chemoradiation therapy. Regional failure is defined as: a) For patients with no disease in pelvic and/or groin nodes, the appearance of disease in pelvic or groin nodes; b) For patients with disease in pelvic and/or groin nodes at study entry, nodal recurrence following clearance or persistent nodal disease for more than 12 weeks after completion of treatment.
Five-Year Cumulative Incidence Rate of Distant Failure From registration to 5 years Distant failure time is defined as time from registration to the appearance of distant metastases and is estimated by the cumulative incidence method. Patients last known to be alive without failure are censored at the date of last contact.
Five-Year Cumulative Incidence Rate of Colostomy Failure From registration to 5 years Colostomy failure time is defined as time from registration to the date of colostomy or abdominoperineal (A-P) resection and is estimated by the cumulative incidence method. Patients last known to be alive without failure are censored at the date of last contact.
Trial Locations
- Locations (172)
St. Mary - Corwin Regional Medical Center
🇺🇸Pueblo, Colorado, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
Boston University Cancer Research Center
🇺🇸Boston, Massachusetts, United States
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital
🇺🇸Boca Raton, Florida, United States
Baptist Medical Center South
🇺🇸Jacksonville, Florida, United States
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Providence Saint Joseph Medical Center - Burbank
🇺🇸Burbank, California, United States
Florida Cancer Center - Palatka
🇺🇸Palatka, Florida, United States
Radiation Oncology Centers - Cameron Park
🇺🇸Cameron Park, California, United States
Radiation Oncology Center - Roseville
🇺🇸Roseville, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center
🇺🇸Carmichael, California, United States
Auburn Radiation Oncology
🇺🇸Auburn, California, United States
Solano Radiation Oncology Center
🇺🇸Vacaville, California, United States
Integrated Community Oncology Network
🇺🇸Jacksonville Beach, Florida, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Bay Medical
🇺🇸Panama City, Florida, United States
Flagler Cancer Center
🇺🇸Saint Augustine, Florida, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
Cancer Institute at St. John's Hospital
🇺🇸Springfield, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Union Hospital Cancer Program at Union Hospital
🇺🇸Elkton, Maryland, United States
Dickinson County Healthcare System
🇺🇸Iron Mountain, Michigan, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
🇺🇸Marlton, New Jersey, United States
Wilmed Radiation Oncology Services
🇺🇸Wilson, North Carolina, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
Methodist Cancer Center at Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Central Indiana Cancer Centers - East
🇺🇸Indianapolis, Indiana, United States
St. Vincent Oncology Center
🇺🇸Indianapolis, Indiana, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Huntsman Cancer Institute at University of Utah
🇺🇸Salt Lake City, Utah, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸Colorado Springs, Colorado, United States
Kansas City Cancer Centers - Southwest
🇺🇸Overland Park, Kansas, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Baptist Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Valley Cancer Center
🇺🇸Spring Valley, Illinois, United States
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
🇺🇸Saint Louis, Missouri, United States
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
🇺🇸Saint Peters, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Kingsbury Center for Cancer Care at Cheshire Medical Center
🇺🇸Keene, New Hampshire, United States
Cancer Institute of New Jersey at Cooper University Hospital - Camden
🇺🇸Camden, New Jersey, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
CCOP - Hematology-Oncology Associates of Central New York
🇺🇸East Syracuse, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Wayne Radiation Oncology
🇺🇸Goldsboro, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center
🇺🇸Akron, Ohio, United States
Summa Center for Cancer Care at Akron City Hospital
🇺🇸Akron, Ohio, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Middletown Regional Hospital
🇺🇸Franklin, Ohio, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
🇺🇸Salem, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Precision Radiotherapy at University Pointe
🇺🇸West Chester, Ohio, United States
Cancer Treatment Center
🇺🇸Wooster, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
St. Luke's Cancer Network at St. Luke's Hospital
🇺🇸Bethlehem, Pennsylvania, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Frankford Hospital Cancer Center - Torresdale Campus
🇺🇸Philadelphia, Pennsylvania, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Texas Oncology, PA at Texas Cancer Center Dallas Southwest
🇺🇸Dallas, Texas, United States
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
🇺🇸Fort Worth, Texas, United States
Texas Oncology, PA at Texas Cancer Center - Sherman
🇺🇸Sherman, Texas, United States
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
🇺🇸Sugar Land, Texas, United States
American Fork Hospital
🇺🇸American Fork, Utah, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
🇺🇸Murray, Utah, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Utah Cancer Specialists at UCS Cancer Center
🇺🇸Salt Lake City, Utah, United States
Norris Cotton Cancer Center - North
🇺🇸Saint Johnsbury, Vermont, United States
Southwest Virginia Regional Cancer Center at Wellmonth Health
🇺🇸Norton, Virginia, United States
Harrison Medical Center
🇺🇸Bremerton, Washington, United States
St. Francis Hospital
🇺🇸Federal Way, Washington, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay
🇺🇸Sturgeon Bay, Wisconsin, United States
Hopital Notre-Dame du CHUM
🇨🇦Montreal, Quebec, Canada
Green Bay Oncology, Limited - Escanaba
🇺🇸Escanaba, Michigan, United States
St. Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Arizona Oncology - Tucson
🇺🇸Tucson, Arizona, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
🇺🇸Vineland, New Jersey, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
Frederick R. and Betty M. Smith Cancer Treatment Center
🇺🇸Sparta, New Jersey, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
Willamette Valley Cancer Center - Eugene
🇺🇸Eugene, Oregon, United States
St. Mary's Hospital Medical Center - Green Bay
🇺🇸Green Bay, Wisconsin, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
Schiffler Cancer Center at Wheeling Hospital
🇺🇸Wheeling, West Virginia, United States
Green Bay Oncology, Limited - Oconto Falls
🇺🇸Oconto Falls, Wisconsin, United States
Sandra L. Maxwell Cancer Center
🇺🇸Cedar City, Utah, United States
Integrated Community Oncology Network at Southside Cancer Center
🇺🇸Jacksonville, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
🇺🇸Jupiter, Florida, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Florida Oncology Associates
🇺🇸Orange Park, Florida, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Reid Hospital & Health Care Services
🇺🇸Richmond, Indiana, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Cascade Cancer Center at Evergreen Hospital Medical Center
🇺🇸Kirkland, Washington, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Northwest Community Hospital
🇺🇸Arlington Heights, Illinois, United States
Galesburg Clinic, PC
🇺🇸Galesburg, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
InterCommunity Cancer Center of Western Illinois
🇺🇸Galesburg, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Radiological Associates of Sacramento Medical Group, Incorporated
🇺🇸Sacramento, California, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
🇺🇸Aurora, Colorado, United States
Saint Joseph Mercy Cancer Center
🇺🇸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
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Kansas City Cancer Centers - South
🇺🇸Kansas City, Missouri, United States
Tom Baker Cancer Centre - Calgary
🇨🇦Calgary, Alberta, Canada
London Regional Cancer Program at London Health Sciences Centre
🇨🇦London, Ontario, Canada
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States