Status:
WITHDRAWN
Image Guided Intensity Modulated Reirradiation (IG-IMRT) With Cetuximab for Locoregionally Confined Recurrent Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Squamous Cell Cancer of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Cetuxim...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00934518
Start Date
July 1 2009
End Date
July 1 2011
Last Update
February 12 2019
Active Locations (1)
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1
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States, 17033