Spots Global Cancer Trial Database for Palifermin in Lessening Oral Mucositis in Patients Undergoing Radiation Therapy and Chemotherapy for Locally Advanced Head and Neck Cancer
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Trial Identification
Brief Title: Palifermin in Lessening Oral Mucositis in Patients Undergoing Radiation Therapy and Chemotherapy for Locally Advanced Head and Neck Cancer
Official Title: A Randomized, Phase III, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Palifermin (NSC# 740548; IND # 6370) for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Radiation Therapy With Concurrent Chemotherapy (Followed by Surgery for Selected Patients)
Study ID: NCT00360971
Study Description
Brief Summary: RATIONALE: Growth factors, such as palifermin, may lessen the severity of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy for head and neck cancer. It is not yet known whether palifermin is more effective than a placebo in lessening mucositis in patients receiving radiation therapy and chemotherapy for head and neck cancer. PURPOSE: This randomized phase III trial is studying palifermin to see how well it works compared to a placebo in lessening oral mucositis in patients undergoing radiation therapy and chemotherapy for locally advanced head and neck cancer.
Detailed Description: OBJECTIVES: Primary * Compare the efficacy of palifermin vs placebo, in terms of burden of acute mucositis (defined to be 105 days \[15 weeks\] or less from the start of treatment), in patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx undergoing concurrent radiotherapy and chemotherapy. Secondary * Compare incidence and time to onset of Grades 3 or 4 oral mucositis in patients treated with these regimens. * Compare overall and progression-free survival and time to second primary in patients treated with these regimens. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (III vs IVA or IVB), tumor site (oral cavity or oropharynx vs hypopharynx or larynx), and radiotherapy technique used on study (intensity-modulated radiotherapy \[IMRT\] vs 3-dimensional conformal radiotherapy \[3D-CRT\]). Patients are randomized to 1 of 2 treatment arms. Mucositis, pain, and symptom burden are assessed at baseline, during radiotherapy, and post radiotherapy. Xerostomia is assessed at baseline, during radiotherapy, and several times after completion of study therapy. After completion of study therapy, patients are followed periodically for 10 years. PROJECTED ACCRUAL: A total of 298 patients will be accrued for this study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
Auburn Radiation Oncology, Auburn, California, United States
Providence Saint Joseph Medical Center - Burbank, Burbank, 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
Enloe Cancer Center at Enloe Medical Center, Chico, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
Radiation Oncology Center - Roseville, Roseville, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento, California, United States
Mercy General Hospital, Sacramento, California, United States
Torrance Memorial Medical Center, Torrance, California, United States
Solano Radiation Oncology Center, Vacaville, California, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Saint John's Cancer Center at Saint John's Medical Center, Anderson, Indiana, United States
St. Agnes Hospital Cancer Center, Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Dickinson County Healthcare System, Iron Mountain, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
William Beaumont Hospital - Royal Oak Campus, Royal Oak, Michigan, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CentraCare Clinic - River Campus, Saint Cloud, Minnesota, United States
Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, United States
Great Falls Clinic - Main Facility, Great Falls, Montana, United States
Cancer Institute of New Jersey at Cooper University Hospital - Camden, Camden, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare, Vineland, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Leo W. Jenkins Cancer Center at ECU Medical School, Greenville, 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
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford, Salem, Ohio, United States
Cancer Treatment Center, Wooster, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Sharon Regional Cancer Care Center- Hermitage, Hermitage, Pennsylvania, United States
Intercommunity Cancer Center, Monroeville, Pennsylvania, United States
Alle-Kiski Medical Center, Natrona Heights, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Somerset Oncology Center, Somerset, Pennsylvania, United States
Mount Nittany Medical Center, State College, Pennsylvania, United States
Johnson City Medical Center Hospital, Johnson City, Tennessee, United States
M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
Schiffler Cancer Center at Wheeling Hospital, Wheeling, West Virginia, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States
Cross Cancer Institute at University of Alberta, Edmonton, Alberta, Canada
Contact Details
Name: David I. Rosenthal, MD
Affiliation: M.D. Anderson Cancer Center
Role: STUDY_CHAIR
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