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

Changjie Huang

Status and phase: Unknown; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Nedaplatin; Radiation: Concurrent Radiotherapy; Drug: Celecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT02537925

NaningSPH_2014

Details and patient eligibility

About

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

Full description

1. Study Patients:

   Patients are all recruited from the Third Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China. All the patients provide written informed consent before enrollment. All eligible patients received a pretreatment evaluation including complete history and physical examination, endoscopic biopsy, routine laboratory tests for hematologic, renal and hepatic function as well as a dental and nutritional evaluation prior to treatment. Radiological investigations consisted of computed tomography (CT) scan or magnetic MRI of the nasopharynx, chest radiography, ultrasound of the upper abdomen and bone scintigraphy. Pathologic confirmation of nasopharyngeal cancer (NPC) was performed and re-classified according to the world health organization (WHO) subtypes.

2. Study design:

   A total of 120 NPC patients are randomly and equally divided into two groups: Nedaplatin alone concurrent radiotherapy, Celecoxib plus nedaplatin concurrent radiotherapy. The tumor response will be evaluated by magnetic resonance imaging (MRI) after 4 weeks. The tumor responses including Complete Response (CR), Partial Response (PR) , Stable Disease (SD) and Progressive Disease (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0. The show term or long term toxicity will be evaluated according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0. All the NPC patients are requested to be followed up with an expected average of every 3 months after the therapy.The other clinical outcomes including the first evidence of cancer progression or death from any cause, the occurrence of distant metastasis, and the relapse of a local or nodal tumor will be evaluated as well. The follow-up will be up to 2018.

3. Statistical Analysis:

Statistical Package for the Social Sciences (SPSS 13.0) is used to analyze the effect of celecoxib on the nedaplatin concurrent radiotherapy. Cox's regression model and Kaplan-Meier method is used to conduct survival analysis. Clinical outcomes including the tumor responses, 1-year/3-year/5-year overall survival (OS), progression free survival (PFS), distant metastasis failure-free survival (DMFS) and locoregional failure-free survival (LFFS) will be analyzed. The multivariate Cox's regression model is used to adjust the confounders, including age and body mass index. P value less than 0.05 will be considered to be statistically significant.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

concurrent_radiochemotherapy

Active Comparator group

Description:

Concurrent radiotherapy with Nedaplatin 40mg/m2/week through intravenous infusion.

Treatment:

Drug: Nedaplatin

Radiation: Concurrent Radiotherapy

celecoxib_radiochemotherapy

Experimental group

Description:

Celecoxib 200mg bid po; Concurrent radiotherapy with Nedaplatin 40mg/m2/week through intravenous infusion.

Treatment:

Drug: Nedaplatin

Drug: Celecoxib

Radiation: Concurrent Radiotherapy