Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery
NCT ID: NCT00113399
Last Updated: 2013-07-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
15 participants
INTERVENTIONAL
2005-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This randomized phase III trial is studying radiation therapy and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating patients with recurrent head and neck cancer that cannot be removed by surgery.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer
NCT00011999
Radiation Therapy and Cisplatin in Treating Patients With Advanced Head and Neck Cancer
NCT00005088
Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
NCT00352118
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
NCT00006051
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced and/or Recurrent Head and Neck Cancer
NCT00004097
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary
* Compare overall survival of patients with previously irradiated unresectable locally recurrent squamous cell carcinoma of the head and neck treated with radiotherapy, cisplatin, and paclitaxel vs cisplatin-based chemotherapy alone.
Secondary
* Compare progression-free survival of patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
* Compare quality of life, functional/performance status, and quality-adjusted survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo radiotherapy twice daily and receive paclitaxel IV over 1 hour and cisplatin IV over 30 minutes once daily on days 1-5, 15-19, 29-33, and 43-47. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 6-13, 20-27, 34-41, and 48-55.
* Arm II: Patients receive 1 of the following cisplatin-based\* regimens at the discretion of the treating physician:
* Regimen 1: Patients receive cisplatin\* IV over 1-2 hours on day 1 and fluorouracil IV continuously over 96 hours on days 1-4.
* Regimen 2: Patients receive cisplatin\* IV over 1-2 hours and paclitaxel IV over 3 hours on day 1.
* Regimen 3: Patients receive cisplatin\* IV over 1-2 hours and docetaxel IV over 1 hour on day 1.
NOTE: \*Carboplatin may be substituted for cisplatin in patients with creatinine clearance \< 50 mL/min or in patients who experience grade 2 or 3 neurotoxicity.
For all regimens, treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond documentation of CR.
Quality of life is assessed at baseline and then at 3, 6, 12, 24, and 36 months.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this study within 5½ years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Radiotherapy and chemotherapy
Radiotherapy/paclitaxel/cisplatin/filgrastim
filgrastim
cisplatin
paclitaxel
radiation therapy
Chemotherapy
Cisplatin/fluorouracil/paclitaxel/docetaxel
cisplatin
docetaxel
fluorouracil
paclitaxel
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
filgrastim
cisplatin
docetaxel
fluorouracil
paclitaxel
radiation therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,800/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
Hepatic
* AST or ALT \< 2 times upper limit of normal (ULN)
* Bilirubin \< 1.5 mg/dL
* No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
Renal
* Creatinine clearance \> 50 mL/min
* Calcium \< 11.5 mg/dL
Cardiovascular
* No New York Heart Association class III or IV heart disease
* No other symptomatic or uncontrolled cardiac disease
Pulmonary
* No chronic obstructive pulmonary disease exacerbation
* No other respiratory illness requiring hospitalization within the past 6 months or that would preclude study therapy
Immunologic
* No AIDS
* No prior allergic reaction to E. coli-derived products
* No acute bacterial or fungal infection requiring IV antibiotics
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 30 days after completion of study treatment
* No other invasive malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the breast, oral cavity, or cervix
* No pre-existing peripheral sensory neuropathy \> grade 2
* No other severe active co-morbidity
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 6 months since prior chemotherapy
* No prior systemic chemotherapy for recurrent SCC of the head and neck
* Prior neoadjuvant, adjuvant, and/or concurrent chemotherapy and radiotherapy for initial SCC of the head and neck allowed
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* See Chemotherapy
* At least 6 months since prior radiotherapy
Surgery
* See Disease Characteristics
Other
* Prior cyclooxygenase-2 inhibitor or retinoids for chemoprevention allowed
* At least 6 months since prior epidermal growth factor receptor (EGFR) inhibitors or other targeted agents
* No prior EGFR inhibitors or other targeted agents for recurrent SCC of the head and neck
* No concurrent cimetidine or allopurinol (for patients on arm II, regimen 1)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stuart J. Wong, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Mobile Infirmary Medical Center
Mobile, Alabama, United States
St. Joseph's Mercy Cancer Center
Hot Springs, Arkansas, United States
Auburn Radiation Oncology
Auburn, California, United States
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
Pomona, California, United States
Radiation Oncology Center - Roseville
Roseville, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Mercy General Hospital
Sacramento, California, United States
Solano Radiation Oncology Center
Vacaville, California, United States
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
Boca Raton, Florida, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
Olympia Fields, Illinois, United States
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
St. John's Cancer Center at St. John's Medical Center
Anderson, Indiana, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Howard Community Hospital at Howard Regional Health System
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States
MaineGeneral Medical Center - Waterville Campus
Waterville, Maine, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
Deaconess Billings Clinic - Downtown
Billings, Montana, United States
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, United States
Long Island College Hospital
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Bismarck Cancer Center
Bismarck, North Dakota, United States
Cancer Care Center at Medcenter One Hospital
Bismarck, North Dakota, United States
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States
St. Alexius Medical Center
Bismarck, North Dakota, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Akron City Hospital
Akron, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital
Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
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
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Northwest Ohio Oncology Center
Maumee, Ohio, United States
Middletown Regional Hospital
Middletown, Ohio, United States
St. Charles Mercy Hospital
Oregon, Ohio, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem, Ohio, United States
Firelands Regional Medical Center
Sandusky, Ohio, United States
Flower Hospital Cancer Center
Sylvania, Ohio, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States
Cancer Treatment Center
Wooster, Ohio, United States
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson AFB, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States
Alle-Kiski Medical Center
Natrona Heights, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States
Cottonwood Hospital Medical Center
Murray, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States
Latter Day Saints Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center - East Campus
St. George, Utah, United States
Norris Cotton Cancer Center - North
Saint Johnsbury, Vermont, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, United States
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States
West Allis Memorial Hospital
West Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDR0000429480
Identifier Type: -
Identifier Source: secondary_id
ECOG-R0421
Identifier Type: -
Identifier Source: secondary_id
RTOG-0421
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.