Chemoradiotherapy With Elective Low Dose Nodal Radiation for Locally Advanced Head and Neck Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Chemoradiotherapy With Very Low Dose Elective Nodal IMRT for Locally Advanced Head & Neck Cancer: the CCRO11 Multi-Institutional Phase II Trial

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: Cisplatin
* Radiation: Elective Nodal Irradiation (ENI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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. Metastatic disease (M1) Pregnant or breast-feeding women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cisplatin|Cisplatin 35 mg/m2 IV weekly during weeks 1 through 6 of IMRT.|
|Radiation: Elective Nodal Irradiation (ENI)|Low risk planning target volume (PTV) of 36 Gy at 2 Gy per fraction daily to bilateral, uninvolved neck nodal regions at risk for harboring microscopic cancer. High risk PTV will receive 70 Gy.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess actuarial LRC, DFS, and OS rates. |  | 4 years | 
| To evaluate patients' quality of life (QOL). |  | 4 years | 
| To evaluate grade 3-5 toxicity by CTCAE v4.0, with special attention to swallowing function, feeding tube dependence, and xerostomia. |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stg III or IVa Squamous Cell Carcinoma., Advanced