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 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT01941992
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven squamous cell carcinomas of the head-and-neck
* Eligible primary tumor sites: oral cavity, oropharynx, larynx, hypopharynx
* Stage III or IV disease without evidence of distant metastases
* Patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemo-radiotherapy
* Age ≥ 18 years
* Karnofsky Performance Status ≥70
* Life expectancy ≥6 months
* Able to swallow and retain oral medication
* Good state of dentition
* Patients must be available for treatment and follow-up
* Confirmation of adequate contraception use by the patient and/or partner
* Signed informed consent
Exclusion Criteria:
* Previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx
* Serious co-morbidities: uncontrolled heart disease, heart failure within 6 months prior to study participation, history of serious neurological and/or psychiatric abnormalities.
* Chronic administration of steroids or immunosuppressants
* Pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01941992
Study Brief:
Protocol Section:
NCT01941992