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Spots Global Cancer Trial Database for Chemotherapy and Radiation Therapy (RT) With or Without Vandetanib in Treating Patients With High-Risk Stage III or Stage IV Head and Neck Cancer

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Trial Identification

Brief Title: Chemotherapy and Radiation Therapy (RT) With or Without Vandetanib in Treating Patients With High-Risk Stage III or Stage IV Head and Neck Cancer

Official Title: A Randomized Phase II Trial of Chemoradiotherapy Versus Chemoradiotherapy and Vandetanib for High-Risk Postoperative Advanced Squamous Cell Carcinoma of the Head and Neck

Study ID: NCT00720083

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving chemotherapy together with radiation therapy is more effective with or without vandetanib in treating patients with head and neck cancer. PURPOSE: This randomized phase II trial is studying giving chemotherapy together with radiation therapy to see how well it works compared with giving chemotherapy and radiation therapy together with vandetanib in treating patients with high-risk stage III or stage IV head and neck cancer.

Detailed Description: OBJECTIVES: Primary * To screen for an indication that the addition of vandetanib to chemoradiotherapy may prolong disease-free survival as compared to a combination of chemoradiotherapy in patients with resected, high-risk stage III or IV head and neck squamous cell carcinoma. Secondary * To determine whether this treatment regimen can be delivered safely and successfully following surgical resection for advanced head and neck cancer. * To estimate the locoregional progression, distant metastasis, and overall survival rates for patients treated with this regimen. * To examine the distribution of selected biomarkers that may include but are not limited to EGFR (epidermal growth factor receptor, total and phosphorylated), E-cadherin, pMAPK (phosphorylated mitogen-activated protein kinase), pAKT, Stat-3 (signal transducer and activator of transcription 3), Ki-67, COX-2 (cyclooxygenase 2), and cyclin B1 (G2/mitotic-specific cyclin-B1)expression in this group of patients and to explore the potential correlation between these markers with the ultimate treatment outcome OUTLINE: This is a multicenter study. Patients are stratified according to Zubrod performance status (0 vs 1) and primary site of disease (oral cavity/hypopharynx vs larynx vs oropharynx, HPV+ (human papillomavirus positive) vs oropharynx, HPV- (human papillomavirus negative)). Patients are randomized to 1 of 2 arms. * Arm I: Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. * Arm II: Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. In both arms, treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Tissue samples from all patients are collected and reviewed. Tissue from patients with oropharyngeal carcinoma is analyzed for human papillomavirus. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 4 years, and then annually thereafter.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mayo Clinic Scottsdale, Scottsdale, Arizona, United States

City of Hope Comprehensive Cancer Center, Duarte, California, United States

Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States

Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento, California, United States

CCOP - Christiana Care Health Services, Newark, Delaware, United States

Mayo Clinic - Jacksonville, Jacksonville, Florida, United States

Winship Cancer Institute of Emory University, Altanta, Georgia, United States

Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey, Illinois, United States

Cancer Institute at St. John's Hospital, Springfield, Illinois, United States

Saint John's Cancer Center at Saint John's Medical Center, Anderson, Indiana, United States

Methodist Cancer Center at Methodist Hospital, Indianapolis, Indiana, United States

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States

James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky, United States

Charach Cancer Center at Huron Valley - Sinai Hospital, Commerce, Michigan, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, United States

Truman Medical Center - Hospital Hill, Kansas City, Missouri, United States

CCOP - Kansas City, Kansas City, Missouri, United States

David C. Pratt Cancer Center at St. John's Mercy, Saint Louis, Missouri, United States

Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center, Lincoln, Nebraska, United States

Renown Institute for Cancer at Renown Regional Medical Center, Reno, Nevada, United States

Memorial Sloan-Kettering Cancer Center - Basking Ridge, Basking Ridge, New Jersey, United States

Radiation Oncology Associates, PA, Albuquerque, New Mexico, United States

University of New Mexico Cancer Center, Albuquerque, New Mexico, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

Memorial Sloan-Kettering Cancer Center, Commack, New York, United States

Highland Hospital of Rochester, Rochester, New York, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States

Memorial Sloan-Kettering Cancer Center - Rockville Centre, Rockville Centre, New York, United States

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow, New York, United States

Leo W. Jenkins Cancer Center at ECU Medical School, Greenville, North Carolina, United States

Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States

Barberton Citizens Hospital, Barberton, Ohio, United States

Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States

Lake/University Ireland Cancer Center, Mentor, Ohio, United States

North Coast Cancer Care, Incorporated, Sandusky, Ohio, United States

Flower Hospital Cancer Center, Sylvania, Ohio, United States

Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States

Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States

Fox Chase Cancer Center Buckingham, Furlong, Pennsylvania, United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading, Pennsylvania, United States

York Cancer Center at Apple Hill Medical Center, York, Pennsylvania, United States

Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States

Rapid City Regional Hospital, Rapid City, South Dakota, United States

M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States

University of Virginia Cancer Center, Charlottesville, Virginia, United States

Sentara Cancer Institute at Sentara Norfolk General Hospital, Norfolk, Virginia, United States

Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States

Schiffler Cancer Center at Wheeling Hospital, Wheeling, West Virginia, United States

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States

St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States

Gundersen Lutheran Center for Cancer and Blood, La Crosse, Wisconsin, United States

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States

Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States

Veterans Affairs Medical Center - Milwaukee, Milwaukee, Wisconsin, United States

Regional Cancer Center at Oconomowoc Memorial Hospital, Oconomowoc, Wisconsin, United States

Waukesha Memorial Hospital Regional Cancer Center, Waukesha, Wisconsin, United States

Contact Details

Name: David Raben, MD

Affiliation: University of Colorado, Denver

Role: PRINCIPAL_INVESTIGATOR

Name: John A. Ridge, MD, PhD

Affiliation: Fox Chase Cancer Center

Role: STUDY_CHAIR

Name: Stuart J. Wong, MD

Affiliation: Medical College of Wisconsin

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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