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

NCT02537925 | Unknown Phase 3 DMC

• 1 other identifier: NaningSPH_2014
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Keywords

COX-2 inhibitors; radiosensitivity; nasopharyngeal carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of patients with different tumor response and short term toxicity will be recorded

  The tumor responses including Complete Response (CR), Partial Response (PR) , Stable Disease (SD) and Progressive Disease (PD) were evaluated by MRI, according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0; Short term toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0.

  Patients are asked to be followed within an expected average of 4 weeks after therapy

Secondary Outcomes (7)

• The date when each patient is dead will be recorded.

  Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the date of first documented death from any cause, assessed up to 36 months.

• The date when each patient shows the first evidence of cancer progression or death from any cause will be recorded.

  Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the date of first documented progression or date of death from any cause, whichever comes first, up to 36 months

• The date when each patient presents the occurrence of distant metastasis will be recorded.

  Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the date of first documented occurrence of distant metastasis, assessed up to 36 months

• The date when each patient presents the relapse of a local or nodal tumor will be recorded.

  Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the date of first documented relapse of a local or nodal tumor, whichever came first, assessed up to 36 months.

• Long term toxicity will be recorded as the Number of Participants with Treatment-Related Adverse Events

  Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the documented date of the Treatment-Related Adverse Events, whichever comes first, assessed up to 36 months.

Study Arms (2)

concurrent_radiochemotherapy

ACTIVE COMPARATOR

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

Drug: Nedaplatin; Radiation: Concurrent Radiotherapy

celecoxib_radiochemotherapy

EXPERIMENTAL

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

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

Interventions

Celecoxib DRUG

Celecoxib 200mg bid po, to the end of concurrent radiotherapy

Also known as: COX-2 inhibitor

celecoxib_radiochemotherapy

Nedaplatin DRUG

40 mg/m2, IV (in the vein) on day 1 of each 7 day cycle. Number of Cycles: to the end of concurrent radiotherapy

celecoxib_radiochemotherapy; concurrent_radiochemotherapy

Concurrent Radiotherapy RADIATION

The standard radiotherapy schedules were available as conventional radiotherapy and Intensity Modulated Radiotherapy (IMRT). The cumulative radiation dose was 68\~74 Gy for primary tumor (2.0\~2.3 Gy/f/day, 5 day/ week, /6\~7 weeks), and 50\~54 Gy for lymphatic positive area (1.8 \~ 2 Gy/f/day, 5 day/week, /5.0\~5.5 weeks).

Also known as: standard radiotherapy schedule

celecoxib_radiochemotherapy; concurrent_radiochemotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changjie Huang: lead

Study Sites (1)

The third Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

Related Publications (2)

• Soo RA, Wu J, Aggarwal A, Tao Q, Hsieh W, Putti T, Tan KB, Low JS, Lai YF, Mow B, Hsu S, Loh KS, Tan L, Tan P, Goh BC. Celecoxib reduces microvessel density in patients treated with nasopharyngeal carcinoma and induces changes in gene expression. Ann Oncol. 2006 Nov;17(11):1625-30. doi: 10.1093/annonc/mdl283. Epub 2006 Sep 28.

  PMID: 17008411 BACKGROUND

• Mohammadianpanah M, Razmjou-Ghalaei S, Shafizad A, Ashouri-Taziani Y, Khademi B, Ahmadloo N, Ansari M, Omidvari S, Mosalaei A, Mosleh-Shirazi MA. Efficacy and safety of concurrent chemoradiation with weekly cisplatin +/- low-dose celecoxib in locally advanced undifferentiated nasopharyngeal carcinoma: a phase II-III clinical trial. J Cancer Res Ther. 2011 Oct-Dec;7(4):442-7. doi: 10.4103/0973-1482.92013.

  PMID: 22269407 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Celecoxib; Cyclooxygenase 2 Inhibitors; nedaplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Changjie Huang

  The third Affiliated Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Mao, M.D.

CONTACT

+8614795721791; zijujuan@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: head of the medical department

Study Record Dates

• First Submitted: May 17, 2015
• First Posted: September 2, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 2, 2015

Record last verified: 2015-08

Locations

CN (1)