Chemoradiotherapy With Elective Low Dose Nodal Radiation for Locally Advanced Head and Neck Cancer
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ClinicalTrials.gov Identifier: NCT01372111
Recruitment Status : Unknown
Verified December 2015 by Coastal Carolina Radiation Oncology. Recruitment status was: Active, not recruiting
Concurrent chemotherapy and radiation therapy (chemoRT) has become the standard of care for treatment of many patients with advanced head and neck squamous cell carcinoma (HNSCC), though many clinical questions remain. Prior experience has revealed locoregional control (LRC), disease free survival (DFS) and overall survival (OS) at 3 years exceeding 80% after treatment with the use of hyperfractionated intensity modulated radiation therapy (IMRT) and concurrent weekly cisplatin chemotherapy for patients with locally advanced HNSCC. This multi-institutional phase II ZCC00204 trial resulted in an acceptable quality of life (QOL) and toxicity profile. The current trial is an attempt to maintain high LRC, while further minimizing both acute and chronic toxicities, and maximizing QOL.
To assess the actuarial elective nodal failure (ENF) rate for patients with locally advanced HNSCC treated with chemoRT including very low dose elective nodal IMRT and concurrent weekly cisplatin. [ Time Frame: 4 years ]
Secondary Outcome Measures :
To assess actuarial LRC, DFS, and OS rates. [ Time Frame: 4 years ]
To evaluate patients' quality of life (QOL). [ Time Frame: 4 years ]
To evaluate grade 3-5 toxicity by CTCAE v4.0, with special attention to swallowing function, feeding tube dependence, and xerostomia. [ Time Frame: 4 years ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Biopsy proven squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, or larynx
No surgical resection of primary site or neck dissection (excisional biopsy of lymph node is permitted)
Human Papilloma Virus (HPV) testing of tumor performed; HPV p16 by immunohistochemistry
Stage III or IVa disease (T1-2N1-3M0, T3-4N0-3M0) excluding T1-2N1 oral cavity and tonsil primaries and any N2C or bilateral N3 disease. Patients with T2N0 cancer of the base of tongue and hypopharynx are eligible
ECOG performance status 0-1
Age >18 years
No current pregnancy
No other invasive malignancies within the last 2 years Patients with basal cell or squamous cell skin cancers or carcinoma in situ of any site are eligible.
No prior radiotherapy to the head and neck region
No prior cisplatin chemotherapy
No symptomatic coronary disease or myocardial infarction within the last 6 months
Laboratory evaluation: ANC > 2,000/mm3, platelets >100,000/mm3, creatinine < 1.5 mg/dl, creatinine clearance > 50 ml/min, bilirubin < 1.5 mg/dl, AST or ALT < 2X upper normal limit
Study-specific consent signed prior to entry
Second primary malignancy that is clinically detectable
Inability or unwillingness to comply with chemoRT
Prior radiotherapy, chemotherapy, or investigational treatment for squamous cell carcinoma of head and neck.