Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: A Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer

Summary: To investigate the efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer following administration of rebamipide and to determine the optimal dose of rebamipide.


Eligibility: 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, ropharynx, 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

Relevance to patient case: not relevant