Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT00934518
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00934518
Study Brief:
Protocol Section:
NCT00934518