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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

Phase 2
18 Years
Open (Enrolling)
Head and Neck Cancer

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Trial Information

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

Inclusion Criteria:

- Biopsy proven squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, or

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Patrick D. Maguire, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Coastal Carolina Radiation Oncology


United States: Institutional Review Board

Study ID:




Start Date:

March 2011

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Stg III or IVa Squamous Cell Carcinoma.
  • Advanced
  • Head and Neck Neoplasms



CarolinaEast Cancer Care New Bern, North Carolina  28560
Coastal Carolina Radiation Oncology Wilmington, North Carolina  28401
Coleman Radiation Oncology Center Morehead City, North Carolina  28557
South Atlantic Radiation Oncology Supply, North Carolina  28462
Zimmer Cancer Center Wilmington, North Carolina  28401