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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01372111
• Other study ID #: CCRO11
• Secondary ID: U54CA142152-02
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 6, 2011
• Last updated: December 8, 2015
• Start date: March 2011

Study information

• Verified date: December 2015
• Source: Coastal Carolina Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Coleman Radiation Oncology Center	Morehead City	North Carolina
United States	CarolinaEast Cancer Care	New Bern	North Carolina
United States	South Atlantic Radiation Oncology	Supply	North Carolina
United States	Coastal Carolina Radiation Oncology	Wilmington	North Carolina
United States	Zimmer Cancer Center	Wilmington	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Coastal Carolina Radiation Oncology	National Cancer Institute (NCI), New Hanover Regional Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To assess actuarial LRC, DFS, and OS rates.		4 years	No
Secondary	To evaluate patients' quality of life (QOL).		4 years	No
Secondary	To evaluate grade 3-5 toxicity by CTCAE v4.0, with special attention to swallowing function, feeding tube dependence, and xerostomia.		4 years	Yes