Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov 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
Sponsor:
Collaborators:
National Cancer Institute (NCI)
New Hanover Regional Medical Center
Information provided by (Responsible Party):
Coastal Carolina Radiation Oncology

Tracking Information
First Submitted Date  ICMJE June 6, 2011
First Posted Date  ICMJE June 13, 2011
Last Update Posted Date December 9, 2015
Study Start Date  ICMJE March 2011
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01372111 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemoradiotherapy With Elective Low Dose Nodal Radiation for Locally Advanced Head and Neck Cancer
Official Title  ICMJE Chemoradiotherapy With Very Low Dose Elective Nodal IMRT for Locally Advanced Head & Neck Cancer: the CCRO11 Multi-Institutional Phase II Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • 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.
Study Arms Not Provided
Publications * 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 10, 2011)
76
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01372111
Other Study ID Numbers  ICMJE CCRO11
U54CA142152-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Coastal Carolina Radiation Oncology
Study Sponsor  ICMJE Coastal Carolina Radiation Oncology
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • New Hanover Regional Medical Center
Investigators  ICMJE
Principal Investigator: Patrick D. Maguire, M.D. Coastal Carolina Radiation Oncology
PRS Account Coastal Carolina Radiation Oncology
Verification Date December 2015

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