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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
New Hanover Regional Medical Center
Information provided by (Responsible Party):
Coastal Carolina Radiation Oncology
ClinicalTrials.gov Identifier:
NCT01372111
First received: June 6, 2011
Last updated: December 8, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Head and Neck Cancer
Drug: Cisplatin
Radiation: Elective Nodal Irradiation (ENI)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Chemoradiotherapy With Very Low Dose Elective Nodal IMRT for Locally Advanced Head & Neck Cancer: the CCRO11 Multi-Institutional Phase II Trial

Resource links provided by NLM:


Further study details as provided by Coastal Carolina Radiation Oncology:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess actuarial LRC, DFS, and OS rates. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • To evaluate patients' quality of life (QOL). [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 76
Study Start Date: March 2011
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cisplatin
    Cisplatin 35 mg/m2 IV weekly during weeks 1 through 6 of IMRT.
    Other Name: Cis-Diamminedichloroplatinum, DDP
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372111

Locations
United States, North Carolina
Coleman Radiation Oncology Center
Morehead City, North Carolina, United States, 28557
CarolinaEast Cancer Care
New Bern, North Carolina, United States, 28561
South Atlantic Radiation Oncology
Supply, North Carolina, United States, 28462
Coastal Carolina Radiation Oncology
Wilmington, North Carolina, United States, 28401
Zimmer Cancer Center
Wilmington, North Carolina, United States, 28401
Sponsors and Collaborators
Coastal Carolina Radiation Oncology
National Cancer Institute (NCI)
New Hanover Regional Medical Center
Investigators
Principal Investigator: Patrick D. Maguire, M.D. Coastal Carolina Radiation Oncology
  More Information

Publications:
Responsible Party: Coastal Carolina Radiation Oncology
ClinicalTrials.gov Identifier: NCT01372111     History of Changes
Other Study ID Numbers: CCRO11  U54CA142152-02 
Study First Received: June 6, 2011
Last Updated: December 8, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Coastal Carolina Radiation Oncology:
Stg III or IVa Squamous Cell Carcinoma.
Advanced

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cisplatin
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 24, 2016