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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT02085460
Eligibility Criteria:
Inclusion Criteria:
* Head and neck cancer patients scheduled for definitive or postoperative chemoradiotherapy.
* Patients with a histopathological diagnosis of head and neck cancer and primary tumor in one of the following regions.
1. Definitive therapy: nasopharynx, oropharynx, hypopharynx, or larynx
2. Postoperative therapy: oral cavity, oropharynx, hypopharynx, or larynx
* Patients with no history of chemotherapy, radiotherapy, or chemoradiotherapy for head and neck cancer
* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Patients who are able to hold fluid in the mouth
* Patients who are able to swallow the investigational medicinal product (IMP)
* Patients expected to survive for at least 3 months
* Patients who have given written informed consent in person
* Patients who can stay at or visit the hospital for scheduled examinations and observations
* Patients who are able to take contraceptive measures to avoid pregnancy of the patient or their partner from the time of informed consent until 4 weeks after completion of IMP administration
Exclusion Criteria:
* Patients with primary malignant tumors other than head and neck cancer.
* Patients with symptomatic viral, bacterial, or fungal infection
* Patients with serious renal impairment
* Patients with distant metastasis
* Patients with severe complications (uncontrolled cardiac disease, diabetes, hypertension, etc)
* Patients with any of the following laboratory test results:
1. Neutrophil count: \<1500 L
2. Platelet count: \<75000 L
3. Hemoglobin: \<10.0 g/L
4. Aspartate aminotransferase (AST): \>3 times the upper limit of the reference value at the trial site
5. Alanine aminotransferase (ALT): \>3 times the upper limit of the reference value at the trial site
6. Serum bilirubin: \>1.5 times the upper limit of the reference value at the trial site
7. Serum albumin: \<3.0 g/dL
8. Serum creatinine: \>1.5 the upper limit of the reference value at the trial site
9. Creatinine clearance : \<30 mL/min
* Patients complicated with autoimmune disease
* Patients requiring continuous systemic administration of glucocorticoid
* Female patients who are pregnant or lactating, who may possibly be pregnant, or who wish to become pregnant
* Patients who have participated in any other clinical trial within 4 weeks prior to initiation of chemoradiotherapy
* Patients who have a history of drug allergy to rebamipide, cisplatin, or other platinum compounds
* Patients who are otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT02085460
Study Brief:
Protocol Section:
NCT02085460