Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Radiation Therapy and Cetuximab in Treating Patients With Recurrent 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: NCT00891904
Recruitment Status : Terminated (Low accrual)
First Posted : May 1, 2009
Results First Posted : March 12, 2014
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE April 30, 2009
First Posted Date  ICMJE May 1, 2009
Results First Submitted Date  ICMJE January 29, 2014
Results First Posted Date  ICMJE March 12, 2014
Last Update Posted Date April 14, 2016
Study Start Date  ICMJE April 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2011)
Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30 [ Time Frame: Daily while on Treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30
Change History Complete list of historical versions of study NCT00891904 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
  • Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients [ Time Frame: 2 years ]
  • Local and Distant Control [ Time Frame: very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter. ]
  • Overall Survival [ Time Frame: very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
  • Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients
  • Local and Distant Control
  • Overall Survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer
Official Title  ICMJE A Feasibility Study of Re-irradiation Using Stereotactic Body Radiation Therapy (SBRT) and Cetuximab for Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Brief Summary

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving stereotactic body radiation therapy together with cetuximab may kill more tumor cells.

PURPOSE: This clinical trial is studying the side effects of radiation therapy given together with cetuximab and to see how well it works in treating patients with recurrent head and neck cancer.

Detailed Description

OBJECTIVES:

Primary

  • To assess the toxicity of stereotactic body radiotherapy delivered concurrently with cetuximab in patients with recurrent squamous cell carcinoma of the head and neck.

Secondary

  • To assess the feasibility of delivering this regimen in these patients.
  • To assess the impact of this regimen on local control, distant control, and overall survival of these patients.

OUTLINE: Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5. Patients undergo 1 fraction of stereotactic-body radiotherapy (RT) in week 2. At 4 weeks after RT completion, patients may receive additional cetuximab IV combined with a 28-day chemotherapy regimen, per investigator discretion.

After completion of study treatment, patients are followed every 2 months for 1 year, every 3-4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • Biological: cetuximab
    Given IV
  • Radiation: stereotactic body radiation therapy
    Undergoing Radiotherapy
Study Arms  ICMJE Experimental: Cetuximab
Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5
Interventions:
  • Biological: cetuximab
  • Radiation: stereotactic body radiation therapy
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 11, 2012)
2
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2009)
20
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the oral cavity, paranasal sinuses, nasopharynx, larynx, hypopharynx, or oropharynx

    • Medically or surgically inoperable disease or patient refuses surgery
    • Recurrent disease
  • Previously irradiated disease meeting the following criteria:

    • Prior radiotherapy completed > 6 months from re-irradiation
    • Prior radiotherapy in the region of the study cancer that would result in overlap of radiation therapy fields
    • Majority of the recurrent tumor volume (> 50%) received prior radiotherapy dose of 30-75 Gy
  • No distant metastatic disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 60 days after completion of study treatment
  • No prior allergic reaction to study drugs

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior surgical resection of the recurrent primary tumor and/or regional lymphatics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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 NCT00891904
Other Study ID Numbers  ICMJE CDR0000640992
RPCI-I-143108
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anurag K. Singh, MD Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date March 2016

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