The Effect of COX-2 Inhibitor on Radiosensitivity in Nasopharyngeal Carcinoma

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether celecoxib is effective in the treatment of nasopharyngeal carcinoma by concurrent chemoradiation with weekly nedaplatin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Changjie Huang
• Treatments: Celecoxib; Cyclooxygenase 2 Inhibitors; Nedaplatin

Criteria

Inclusion criteria:

• Patients with NPC newly diagnosed by histopathology, and without radiotherapy or chemotherapy before the clinical trial

• Patients with measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) criteria

• With the Eastern Cooperative Oncology Group Performance Status (ECOG PS) as 0-1 score

• Serum hemoglobin ≥10gm/dL, platelet ≥100000/μL, neutrophil granulocyte absolute counting is 1500/μL

• Serum creatinine ≤1.25 times of upper normal limit (UNL), creatinine clearance rate ≥ 60 ml/min

• Serum bilirubin ≤ 1.5times of UNL, serum aspartate aminotransferase (AST) or glutamic-oxaloacetic transaminase(GOT)≤ 2.5 times of UNL, serum alanine aminotransferase (ALT) or glutamic-pyruvic transaminase (GPT) ≤ 2.5 times of UNL, alkaline phosphatase≤5 times of UNL

• The estimate overall survival (OS)> 6 months

• With formal informed consent forms signed.

Exclusion criteria:

• With symptomatic brain/bone metastases,

• With cognitive impairment or other malignancies

• With any contraindications for radiotherapy and chemotherapy (such as active phase of infection, myocardial infarction within 6 months, symptomatic heart disease, including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmias, in current immunosuppressive therapy)

• Current pregnancy, lactating women or women with fertility but don't take contraceptive measures yet

• With severe bone marrow dysfunction

• With bleeding tendency

• With abuse of drugs or alcohol addicts

• Who may have III-IV type of allergic reactions to any treatment in this study

• With termination of trial because of intolerable toxicity, other study drugs using during the clinical study, or unwilling to continue the treatment.