Overview

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.