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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT01326468
Eligibility Criteria:
Inclusion Criteria:
Cohort A:
* Stage III or IVA-B HNC without prior RT except non-sm0kers with human papillomavirus (HPV) + nasopharynx and oropharynx. HPV+ oropharynx patients who have smoked regularly in the past 5 years are eligible.
* Patients with local or regional recurrence after surgery alone are eligible, as long as the recurrent stage is III or IVA-B
* Age \> or = 18
* Karnofsky performance status \> 70
* No severe active infection requiring intravenous antibiotics (oral antibiotics are allowable).
* Adequate renal function (creatinine \< 1.5 mg/dl), based upon blood work performed within 1 month prior to registration.
* Adequate hepatic function (alkaline phosphatase and AST/ALT \< 2 x ULN) based upon bloodwork performed within 1 month prior to registration.
* Adequate bone marrow function (ANC \> 1.5; platelets \> 100K) based upon blood work performed within one month prior to registration.
* Adequate cardiopulmonary function (no signs of acute coronary event and/or active CHF).
* No plans for other concurrent radiation therapy, chemotherapy or biologic anti-cancer therapy.
Cohort B:
* Platinum ineligible patients as defined by the multidisciplinary team.
* Stage III or IVA-B HNC without prior RT except nonsmokers with HPV + nasopharynx and oropharynx. HPV+ oropharynx patients who have smoked regularly in the past 5 years are eligible.
* Patients with local or regional recurrence after surgery alone are eligible, as long as the recurrent stage is III or IVA-B
* Age \> or = 18
* KPS \> 70
* No severe active infection requiring intravenous antibiotics (oral antibiotics are allowable).
* Adequate hepatic function (alkaline phosphatase and AST/ALT \< 2 x ULN) based upon bloodwork performed within 1 month prior to registration.
* Adequate bone marrow function (ANC \> 1.5; platelets \> 100K) based upon bloodwork performed within one month prior to registration.
* Adequate cardiopulmonary function (no signs of acute coronary event and/or active CHF).
* No plans for other concurrent radiation therapy, chemotherapy or biologic anti-cancer therapy.
Exclusion Criteria:
* Current, recent (within 4 weeks of enrollment in this study) or planned participation in an experimental drug study other than this one.
* KPS \< 70%
* Expected survival \< 6 months
* Early stage head and neck cancer as defined as T1N0 or T2N0 by AJCC 7th edition
* Poorly controlled blood pressure, defined as systolic bp \> 150 and/or diastolic bp \> 100 despite medication.
* Unstable angina.
* NY Heart Association (NYHA) Grade II or greater congestive heart failure.
* History of myocardial infarction or stroke within 6 months.
* Clinically significant peripheral vascular disease.
* Evidence of bleeding diathesis or coagulopathy.
* Presence of brain or spinal cord metastases.
* Major surgical procedure(s), open biopsy or significant traumatic injury within 14 days prior to initiation of radiation therapy and/or anticipation of need for major surgical procedure during the course of the study.
* Minor surgical procedures such as needle/core biopsies, dental work, PEG placement, tracheostomy within 10 days prior to initiation of radiation therapy.
* Carotid artery exposure or other signs of impending carotid artery hemorrhage.
* History of abdominal fistula and/or gastrointestinal abdominal abscess within 6 months prior to enrollment.
* Serious, non-healing wound, ulcer, or bone fracture.
* Prior irradiation that would result in radiotherapy field "overlap."
* Requirement for high dose oral anticoagulation (i.e., goal INR \> 2.0). "Mini-dose" anticoagulation may be used to assist in patency of central venous lines. Subcutaneous low-molecular weight heparin is allowable.
* No known allergies to any of the drug therapies being used in this protocol.
* No pregnancy, lactation or inability to use medically acceptable birth control if of childbearing potential.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01326468
Study Brief:
Protocol Section:
NCT01326468