Trial record 39 of 59 for:    dry mouth | NIH

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01372111
Recruitment Status : Unknown
Verified December 2015 by Coastal Carolina Radiation Oncology.
Recruitment status was:  Active, not recruiting
First Posted : June 13, 2011
Last Update Posted : December 9, 2015
National Cancer Institute (NCI)
New Hanover Regional Medical Center
Information provided by (Responsible Party):
Coastal Carolina Radiation Oncology

June 6, 2011
June 13, 2011
December 9, 2015
March 2011
March 2016   (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 ]
Same as current
Complete list of historical versions of study NCT01372111 on Archive Site
  • To assess actuarial LRC, DFS, and OS rates. [ Time Frame: 4 years ]
  • To evaluate patients' quality of life (QOL). [ Time Frame: 4 years ]
  • 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 ]
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
Phase 2
Intervention Model: Single Group Assignment
Masking: None (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. doi: 10.1016/j.ijrobp.2009.12.046. Epub 2010 Apr 8.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Not Provided
March 2016   (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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
U54CA142152-02 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Coastal Carolina Radiation Oncology
Coastal Carolina Radiation Oncology
  • National Cancer Institute (NCI)
  • New Hanover Regional Medical Center
Principal Investigator: Patrick D. Maguire, M.D. Coastal Carolina Radiation Oncology
Coastal Carolina Radiation Oncology
December 2015

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