This trial is active, not recruiting.

Condition head and neck cancer
Treatments cisplatin, elective nodal irradiation (eni)
Phase phase 2
Sponsor Coastal Carolina Radiation Oncology
Collaborator National Cancer Institute (NCI)
Start date March 2011
End date March 2016
Trial size 76 participants
Trial identifier NCT01372111, CCRO11, U54CA142152-02


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

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 Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Chemoradiotherapy With Very Low Dose Elective Nodal IMRT for Locally Advanced Head & Neck Cancer: the CCRO11 Multi-Institutional Phase II Trial
Principal investigator Patrick D. Maguire, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Coastal Carolina Radiation Oncology.