None listed
Conditions
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.
Interventions
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
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.
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
15 Years to 80 Years
Healthy volunteers
No
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
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,
Outcome results
None listed