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 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT02158234
Eligibility Criteria:
Inclusion Criteria:
* Recurrence of previously pathologically proven squamous cell carcinoma of the head and neck, including original primary sites in the paranasal sinuses, nasal cavity, nasopharynx, oropharynx, oral cavity, larynx, hypopharynx, salivary glands, and/or involvement of cervical lymph nodes
* Prior radiotherapy to doses ≥ 45 Gy to the area of recurrence, ≥ 6 months prior to enrollment
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2
* Life expectancy \> 6 months
* Medically unfit for surgery or deemed surgically unresectable by head and neck (H\&N) surgeon within 60 days prior to enrollment, or patient refusal of surgery
* Normal organ and marrow function
* No prior evidence of Grade 3 or greater toxicity or neuropathy
* Medically fit to receive cisplatin
Exclusion Criteria:
* Positive urine pregnancy test and/or breastfeeding. Women of childbearing potential or sexually active males must be willing to use effective contraception throughout their participation in the treatment phase of the study.
* Evidence of distant metastases
* Tumor size \> 7 cm in one direction
* Tumor within 1 cm of the spinal cord
* Cardiac history: class III or greater congestive heart failure (CHF) or myocardial infarction (MI) within last 6 months
* Medical condition or social situation that at the discretion of the principal investigator (PI) would preclude them from completion of the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02158234
Study Brief:
Protocol Section:
NCT02158234