Back to resultsImage Guided Intensity Modulated Reirradiation (IG-IMRT) With Cetuximab for Locoregionally Confined Recurrent Head and Neck Squamous Cell Carcinoma
Primary Purpose
Squamous Cell Cancer of the Head and Neck
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Radiation
Cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Cancer of the Head and Neck focused on measuring Squamous cell carcinoma, Head and Neck cancer
Eligibility Criteria
Inclusion Criteria:
- Patients must have a pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer in the upper aerodigestive tract or a second squamous cell primary. Patients may have experienced more than one recurrence as long as the first recurrence occurred ≥6 months following the end of the prior RT.
- The recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence).
- The majority (≥75%) of the tumor volume must have been in areas previously irradiated to ≥45 Gy. The previous irradiation must not exceed a maximum of 75 Gy.
- Patients must be at least 6 months from prior radiation therapy.
- If a resection is performed after the diagnosis of recurrence and before enrollment, either microscopic or macroscopic disease must be present (i.e. positive margins or gross residual).
- Karnofsky Performance Status 60-100.
- Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, bilirubin ≤ 1.5 mg/dl, creatinine ≤ 1.5 mg/dl, within 6 weeks prior to registration.
- Must be able to submit previous radiation records (simulation and portal film if available) in order to assure that cord tolerance is not exceeded.
- Patients must sign a study-specific informed consent form prior to study entry.
- The patient must be between the ages of 18 and 75.
Exclusion Criteria:
- Distant metastases.
- Completely resected recurrence with negative margins.
- Other concurrent invasive malignancies.
- Prior invasive malignancy unless disease free for at least two years (prior in situ malignancies are permissible).
- Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
- Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
- Previous treatment with cetuximab.
Sites / Locations
- Penn State Hershey Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiation and Cetuximab
Arm Description
Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week Cetuximab 400 mg/m2 of body surface area over a period of 120 minutes day 1 250 mg/m2 of body surface area over a period of 60 minutes weekly during radiation
Outcomes
Primary Outcome Measures
To estimate the incidence rate of acute and late toxicities associated with combined cetuximab and image guided intensity modulated reirradiation in patients with recurrent squamous cell cancer of the head and neck.
Secondary Outcome Measures
To estimate the median and one-year, disease-free, and overall survival rates of the treated patients.
To determine the pattern of disease progression in treated patients.
To identify the impact of cetuximab and image guided intensity modulated reirradiation on patients' quality of life.
Full Information
NCT ID
NCT00934518
First Posted
July 7, 2009
Last Updated
February 8, 2019
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00934518
Brief Title
Image Guided Intensity Modulated Reirradiation (IG-IMRT) With Cetuximab for Locoregionally Confined Recurrent Head and Neck Squamous Cell Carcinoma
Official Title
Image Guided Intensity Modulated Reirradiation With Concurrent Cetuximab in the Treatment of Locoregionally Confined Relapsed Squamous Cell Carcinoma of the Head and Neck
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Inadequate patient accrual
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The standard treatment for head and neck cancer relapses in previously irradiated patients is controversial. Reirradiation has had some success, but many patients still die from their disease. Cetuximab is helpful in relapsed head and neck cancer, and it improves the effectiveness of radiation in some head and neck cancer patients. But, it has not been studied with reirradiation. The purpose of this study is to see the effects, both good and bad, of reirradiation with cetuximab.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Cancer of the Head and Neck
Keywords
Squamous cell carcinoma, Head and Neck cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiation and Cetuximab
Arm Type
Experimental
Arm Description
Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week
Cetuximab 400 mg/m2 of body surface area over a period of 120 minutes day 1 250 mg/m2 of body surface area over a period of 60 minutes weekly during radiation
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week
Cetuximab 400 mg/m2 of body surface area over a period of 120 minutes day 1 250 mg/m2 of body surface area over a period of 60 minutes weekly during radiation
Primary Outcome Measure Information:
Title
To estimate the incidence rate of acute and late toxicities associated with combined cetuximab and image guided intensity modulated reirradiation in patients with recurrent squamous cell cancer of the head and neck.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
To estimate the median and one-year, disease-free, and overall survival rates of the treated patients.
Time Frame
5 years
Title
To determine the pattern of disease progression in treated patients.
Time Frame
5 years
Title
To identify the impact of cetuximab and image guided intensity modulated reirradiation on patients' quality of life.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have a pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer in the upper aerodigestive tract or a second squamous cell primary. Patients may have experienced more than one recurrence as long as the first recurrence occurred ≥6 months following the end of the prior RT.
The recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence).
The majority (≥75%) of the tumor volume must have been in areas previously irradiated to ≥45 Gy. The previous irradiation must not exceed a maximum of 75 Gy.
Patients must be at least 6 months from prior radiation therapy.
If a resection is performed after the diagnosis of recurrence and before enrollment, either microscopic or macroscopic disease must be present (i.e. positive margins or gross residual).
Karnofsky Performance Status 60-100.
Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, bilirubin ≤ 1.5 mg/dl, creatinine ≤ 1.5 mg/dl, within 6 weeks prior to registration.
Must be able to submit previous radiation records (simulation and portal film if available) in order to assure that cord tolerance is not exceeded.
Patients must sign a study-specific informed consent form prior to study entry.
The patient must be between the ages of 18 and 75.
Exclusion Criteria:
Distant metastases.
Completely resected recurrence with negative margins.
Other concurrent invasive malignancies.
Prior invasive malignancy unless disease free for at least two years (prior in situ malignancies are permissible).
Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
Previous treatment with cetuximab.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heath B Mackley, MD
Organizational Affiliation
Penn State Hershey Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Cancer Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Image Guided Intensity Modulated Reirradiation (IG-IMRT) With Cetuximab for Locoregionally Confined Recurrent Head and Neck Squamous Cell Carcinoma
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