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:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT00140556
Eligibility Criteria:
Inclusion Criteria:
* Locally advanced squamous carcinoma of the head and neck (AJCC stages II/IV, M0, and excluding T1N1 and T1N2) undergoing curative intent concurrent chemoradiation.
* Previous treatment of any sort other than a biopsy is not allowed.
* Eligible anatomic sites:
* oral cavity
* oropharynx
* hypopharynx
* supraglottic
* glottic larynx
* KPS \> 60
Exclusion Criteria:
* Nasopharynx primary
* History of malignancy other than basal cell skin cancer.
* History of claudication, bleeding, or thromboembolic disorders. Patients receiving heparin or Coumadin therapy are ineligible.
* Primary tumor or lymph node encasement of the carotid artery
* Blood pressure of \>150/100 mmHg
* Unstable angina
* New York Heart Association (NYHA) Grade II or greater congestive heart failure
* History of myocardial infarction within 6 months
* History of stroke within 6 months
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0; anticipation of need for major surgical procedure during the course of the study.
* Minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to Day 0
* Pregnant (positive pregnancy test) or lactating
* Urine protein : creatinine ratio ≥ 1.0 at screening
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
* Serious, non-healing wound, ulcer, or bone fracture
* AST, ALT, or bilirubin \> 1.5 x normal
* PT or PTT \> 1.5 x normal
* Platelets \< 100,000
* WBC \< 2000
* Hgb \< 10
* Creatinine clearance \< 60 mL/hr
* Refusal to provide written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00140556
Study Brief:
Protocol Section:
NCT00140556