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

Coastal Carolina Radiation Oncology

Status and phase

Unknown

Phase 2

Conditions

Head and Neck Cancer

Treatments

Radiation: Elective Nodal Irradiation (ENI)

Drug: Cisplatin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01372111

U54CA142152-02 (U.S. NIH Grant/Contract)

CCRO11

Details and patient eligibility

About

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.

Enrollment

76 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.