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

This study is currently recruiting participants.
Verified June 2011 by New Hanover Regional Medical Center
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Coastal Carolina Radiation Oncology (CCRO)
Information provided by:
New Hanover Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01372111
First received: June 6, 2011
Last updated: June 10, 2011
Last verified: June 2011
History of Changes

June 6, 2011
June 10, 2011
March 2011
March 2014   (final data collection date for primary 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. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01372111 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Chemoradiotherapy With Elective Low Dose Nodal Radiation for Locally Advanced Head and Neck Cancer
Chemoradiotherapy With Very Low Dose Elective Nodal IMRT for Locally Advanced Head & Neck Cancer: the CCRO11 Multi-Institutional Phase II Trial

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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • 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.
Not Provided
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. Epub 2010 Apr 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
76
Not Provided
March 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Deborah Brasic, FNP 910-251-1839 dbrasic@ccradonc.com
Contact: Lynette Racco, RN, BSN, OCN 910-343-4075 lynette.racco@nhrmc.org
United States
 
NCT01372111
CCRO11, U54CA142152-02
No
Patrick D. Maguire, M.D., CCRO
New Hanover Regional Medical Center
  • National Cancer Institute (NCI)
  • Coastal Carolina Radiation Oncology (CCRO)
Principal Investigator: Patrick D. Maguire, M.D. Coastal Carolina Radiation Oncology
New Hanover Regional Medical Center
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP