Back to resultsRadiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer
Primary Purpose
Head and Neck Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cetuximab
stereotactic body radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
Eligibility Criteria
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
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cetuximab
Arm Description
Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5
Outcomes
Primary Outcome Measures
Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30
Secondary Outcome Measures
Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients
Local and Distant Control
Overall Survival
Full Information
NCT ID
NCT00891904
First Posted
April 30, 2009
Last Updated
March 14, 2016
Sponsor
Roswell Park Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT00891904
Brief Title
Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cetuximab
Arm Type
Experimental
Arm Description
Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5
Intervention Type
Biological
Intervention Name(s)
cetuximab
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
stereotactic body radiation therapy
Intervention Description
Undergoing Radiotherapy
Primary Outcome Measure Information:
Title
Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30
Time Frame
Daily while on Treatment
Secondary Outcome Measure Information:
Title
Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients
Time Frame
2 years
Title
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.
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anurag K. Singh, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer
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