Clinical trial NCT01372111: Chemoradiotherapy With Elective Low Dose Nodal Radiation for Locally Advanced Head and Neck Cancer
Official title: Chemoradiotherapy With Very Low Dose Elective Nodal IMRT for Locally Advanced Head & Neck Cancer: the CCRO11 Multi-Institutional Phase II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: Stg III or IVa Squamous Cell Carcinoma.
Advanced
Lead sponsor: Coastal Carolina Radiation Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: New Hanover Regional Medical Center
First posted: 2011-06-13
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 4 years
Secondary outcomes:
measure: To assess actuarial LRC, DFS, and OS rates.
timeFrame: 4 years
measure: To evaluate patients' quality of life (QOL).
timeFrame: 4 years
measure: To evaluate grade 3-5 toxicity by CTCAE v4.0, with special attention to swallowing function, feeding tube dependence, and xerostomia.
timeFrame: 4 years
Other outcomes:
Locations:
city: Morehead City
country: United States
facility: Coleman Radiation Oncology Center
state: North Carolina
city: New Bern
country: United States
facility: CarolinaEast Cancer Care
state: North Carolina
city: Supply
country: United States
facility: South Atlantic Radiation Oncology
state: North Carolina
city: Wilmington
country: United States
facility: Coastal Carolina Radiation Oncology
state: North Carolina
city: Wilmington
country: United States
facility: Zimmer Cancer Center
state: North Carolina
Study officials:
affiliation: Coastal Carolina Radiation Oncology
name: Patrick D. Maguire, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maguire PD, Papagikos M, Hamann S, Neal C, Meyerson M, Hayes N, Ungaro P, Kotz K, Couch M, Pollock H, Tepper J. Phase II trial of hyperfractionated intensity-modulated radiation therapy and concurrent weekly cisplatin for Stage III and IVa head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2011 Mar 15;79(4):1081-8. doi: 10.1016/j.ijrobp.2009.12.046. Epub 2010 Apr 8.