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 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT02013050
Eligibility Criteria:
Inclusion Criteria:
* Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT.
* Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation.
* Planned to receive standard cisplatin chemotherapy administered either weekly or every third week.
* Must be able to read and understand informed consent
* Adequate birth control methods for the duration of the study
Exclusion Criteria:
* Current mucositis.
* Prior radiation to the head and neck.
* Chemotherapy treatment within the previous 12 months.
* Tumors of the lips, sinuses, salivary glands or nasopharynx.
* Unknown primary tumor.
* Stage 4c metastases.
* Evidence of significant hepatic, hematologic, or immunologic disease.
* Women who are pregnant or breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02013050
Study Brief:
Protocol Section:
NCT02013050