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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00720083 |
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.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: cisplatin Drug: vandetanib Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
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 |
Estimated Enrollment: | 170 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
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. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. |
Drug: cisplatin
Given IV
Radiation: radiation therapy
Patients undergo radiotherapy 5 times a week for up to 6.5 weeks.
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Arm II: Experimental
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. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: cisplatin
Given IV
Drug: vandetanib
Given orally
Radiation: radiation therapy
Patients undergo radiotherapy 5 times a week for up to 6.5 weeks.
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OBJECTIVES:
Primary
Secondary
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+ vs oropharynx, HPV-). Patients are randomized to 1 of 2 arms.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma of the head and neck, including any of the following subtypes:
Must have undergone gross total resection* (with curative intent) within 3-6 weeks of registration, with pathology demonstrating 1 or more of the following risk factors:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Prior invasive malignancy (except nonmelanoma skin cancer) unless disease free for a minimum of 3 years with the exception of the following:
Severe, active co-morbidity, defined as follows:
History of arrhythmia (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE grade 3), or asymptomatic sustained ventricular tachycardia
QTc with Bazett's correction that is unmeasurable or ≥ 480 msec on screening EKG
PRIOR CONCURRENT THERAPY:
Principal Investigator: | David Raben, MD | University of Colorado at Denver and Health Sciences Center |
Investigator: | John A. Ridge, MD, PhD | Fox Chase Cancer Center |
Investigator: | Stuart J. Wong, MD | Medical College of Wisconsin |
Responsible Party: | Radiation Therapy Oncology Group ( Walter John Curran, Jr ) |
Study ID Numbers: | CDR0000599867, RTOG-0619 |
Study First Received: | July 19, 2008 |
Last Updated: | August 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00720083 History of Changes |
Health Authority: | Unspecified |
stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx |
stage III verrucous carcinoma of the oral cavity stage IV verrucous carcinoma of the oral cavity stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx |
Cisplatin Laryngeal Carcinoma Head and Neck Neoplasms Epidermoid Carcinoma Carcinoma, Squamous Cell of Head and Neck Neoplasms, Squamous Cell |
Squamous Cell Carcinoma Carcinoma, Squamous Cell Hypopharyngeal Cancer Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Head and Neck Neoplasms |
Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Carcinoma |