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Trial registered on ANZCTR


Registration number
ACTRN12608000449336
Ethics application status
Approved
Date submitted
14/08/2008
Date registered
12/09/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Phase II/III Trial of Weekly Cisplatin Chemoradiotherapy +/- low-dose celecoxib for locoregional nasopharyngeal carcinoma
Scientific title
A Randomised Phase II/III Trial to evaluate the efficacy and safety of Weekly Cisplatin Chemoradiotherapy +/- low-dose celecoxib for locoregional nasopharyngeal carcinoma
Secondary ID [1] 252848 0
There is no secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nasopharyngeal cancer 3563 0
Condition category
Condition code
Cancer 3719 3719 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two arm randomized placebo controlled phase II/III study evaluating the efficacy and safety of the combined low-dose oral celecoxib and concurrent weekly intravenous cisplatin chemoradiation in patients with locoregional nasopharyngeal carcinoma
Fifty eligible patients with pathologically proven nasopharyngeal carcinoma are enrolled.
Study arm:
chemotherapy consisting of intravenous cisplatin 30 mg/m2 every 7 days concurrently with radiation therapy (70 Gy, 10 Gy/week) for seven weeks, followed by sequential chemotherapy with intravenous cisplatin 70 mg/m2 plus 5-Fluorouracil (5-Fu) 750 mg/m2 every three weeks for three cycles. There is two weeks resting period between the completion of chemoradiation and starting the cycles of sequential intravenous chemotherapy with cisplatin and 5-FU. These patients receive oral celecoxib 200 mg/day during chemoradiation and up to 3 months following completion of chemoradiotherapy.
The duration of intervention is 20 weeks.
Intervention code [1] 3277 0
Treatment: Drugs
Comparator / control treatment
Control arm:
chemotherapy consisting of intravenous cisplatin 30 mg/m2 every 7 days concurrently with radiation therapy (70 Gy, 10 Gy/week) for seven weeks, followed by sequential chemotherapy with intravenous cisplatin 70 mg/m2 plus 5-Fluorouracil (5-Fu) 750 mg/m2 every three weeks for three cycles. These patients receive oral starch capsule as placebo from the first day of chemoradiation to 3 months following completion of chemoradiotherapy.
Control group
Placebo

Outcomes
Primary outcome [1] 4624 0
Clinical response rates determined based on the direct endoscopic ear, nose throat (ENT) and physical examination and imaging [(Computed Tomography (CT) scan and Magnetic Resonance Image (MRI)] findings
Timepoint [1] 4624 0
Direct endoscopic ENT and physical examination and imaging (CT scan and MRI) will be performed 3 months following completion of chemoradiotherapy.
Secondary outcome [1] 7819 0
Acute treatment-related toxicities will be measured by clinician assessment and graded according to the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer(RTOG/EORTC) Late Radiation Morbidity Scoring Schema.
Timepoint [1] 7819 0
Acute treatment-related toxicites will be assessed at baseline, weekly during concurrent chemoradiotherapy and at the end of every sequential chemotherapy cycle.

Eligibility
Key inclusion criteria
1. Pathologically proven locoregional nasopharyngeal carcinoma.
2. No prior therapy
3. No clinical or imaging evidence of distant metastasis at the time of study enrollment
4. Karnofsky performance status = 70
5. Written informed consent
6. Normal or acceptable liver, kidney and bone marrow function
Minimum age
15 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior therapy
2. Clinical or imaging evidence of distant metastasis
3. Patients with a known contraindication (e.g. gastric ulcer) or allergy to COX-2 inhibitors
4. Patients with severe heart, cardiovascular, liver, renal, inflammatory intestinal or blood coagulation disorders,

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization is performed by computer at central administration site.
The blinding is performed by a person not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by using a randomization table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1161 0
Iran, Islamic Republic Of
State/province [1] 1161 0
Fars

Funding & Sponsors
Funding source category [1] 3742 0
University
Name [1] 3742 0
Shiraz University of Medical Sciences
Address [1] 3742 0
Shiraz University of Medical Sciences, Shiraz 71936, Iran
Country [1] 3742 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Shiraz University of Medical Sciences
Address
Shiraz University of Medical Sciences, Shiraz 71936, Iran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 3356 0
None
Name [1] 3356 0
Address [1] 3356 0
Country [1] 3356 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5794 0
Ethical approval obtained from the Ethical Review Committee of Shiraz University of Medical Sciences. (Ref: 86-2664)
Ethics committee address [1] 5794 0
Ethical Review Committee of Shiraz University of Medical Sciences, Shiraz University of Medical Sciences, Shiraz 71936, Iran
Ethics committee country [1] 5794 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 5794 0
12/11/2007
Approval date [1] 5794 0
07/12/2007
Ethics approval number [1] 5794 0
Ref: 86-2664

Summary
Brief summary
Nasopharyngeal carcinoma (NPC) is a special entity in which the location does not lend itself to curative surgery. NPC is highly radiosensitive, and radical external beam radiotherapy is the mainstay of treatment for this neoplasm and its regional lymph node metastasis. Concurrent cisplatin-based chemoradiation with or without sequential adjuvant chemotherapy is currently the standard care for locoregionally advanced nasopharyngeal carcinoma. Patients with NPC tend to have advanced disease at the time of presentation. Locoregional and systemic failures are high in these patients and contribute to the poor survival. More effective chemotherapeutic regimens and other systemic therapy are needed to decrease the rate of locoregional and distant failure and improve survival. COX-2 inhibitors are among the promising agents. Celecoxib is a potent radiosensitizer and anti-inflamatory agent which can potentially enhance the effect of radiotherapy and reduce the radiation-induced mucositis.
Trial website
www.sums.ac.ir
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28849 0
Address 28849 0
Country 28849 0
Phone 28849 0
Fax 28849 0
Email 28849 0
Contact person for public queries
Name 12006 0
Mohammad Mohammadianpanah
Address 12006 0
Department of Radiation Oncology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz 71936-13311, Iran
Country 12006 0
Iran, Islamic Republic Of
Phone 12006 0
+98 711 6474320
Fax 12006 0
+98 711 6474320
Email 12006 0
mohpanah@gmail.com
Contact person for scientific queries
Name 2934 0
Mohammad Mohammadianpanah
Address 2934 0
Department of Radiation Oncology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz 71936-13311, Iran
Country 2934 0
Iran, Islamic Republic Of
Phone 2934 0
+98 711 6474320
Fax 2934 0
+98 711 6474320
Email 2934 0
mohpanah@sums.ac.ir

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary