NCT03890185

Docetaxal & Cisplatin vs LDFRT + Docetaxal & Cisplatin in Locally Advanced NPC

Randomized Phase II Trial of Docetaxal and Cisplatin Versus Low-Dose Fractionated Radiation Plus Docetaxal and Cisplatin as Induction Therapy in Locally Advanced Nasopharyngeal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: King Faisal Specialist Hospital & Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The central hypothesis is to test Low Dose Fraction Radiotherapy (LDFRT), as a potentiator of Docetaxel and Cisplatin efficacy in locally advanced nasopharyngeal cancer.

Detailed description

Nasopharyngeal cancer is the commonest cancer of the head and neck in Saudi Arabia and constitutes nearly a half (44%) of all head and neck cancers diagnosed annually according to the National Cancer Registry Data. Majority of our patients present with locally advance disease which adversely affect their treatment outcome. The treatment of this disease has evolved over the last several years and several Phase III trials have now shown that combined chemotherapy and radiation are significantly superior to treatment with radiation therapy alone. However, results for treatment of the Stage III and IV disease remains less than satisfactory with a 5-year survival of 60-70 %. Recent data in other head and neck cancer sites including nasopharyngeal cancer indicates that the use of chemotherapy in combination with radiation may improve the outcome of therapy primarily by a reduction in the rate of distant metastasis. Induction chemotherapy alone has, however, failed to show an improvement in survival compared to radiation therapy alone. The administration of induction chemotherapy followed by concurrent chemo-radiation appears the most promising approach. Our experience at KFSH\&RC with induction chemotherapy followed by chemo-radiation in Stage IV cancers, still reveals that approximately 25- 30% of patients will develop local relapse in the nasopharyngeal site; and 35- 40 % of patients are likely to develop distant metastasis. The most promising recent schedule of induction chemotherapy has been the use of Docetaxel and Cisplatin followed by concurrent Cisplatin and radiation. A recent Phase II study demonstrated that the three-year progression-free survival and overall survivals was improved with the use of this induction regimen. A variety of treatment strategies are currently being investigated in hope of achieving improved local control and enhanced survival of patients. These include addition of new chemotherapy drugs, other targeted agents such as Bevacizumab, Cetuximab, etc and radiation fractionation. The rationale for using neoadjuvant chemotherapy is that a reduction in the overall tumor burden will permit more effective local therapy and reduce the rates of distant metastases. Neoadjuvant cisplatin / docetaxel are active agents for locally advanced nasopharyngeal cancer. The addition of docetaxel to platinum containing neoadjuvant chemotherapy in other locally advanced head and neck squamous-cell carcinoma have also been shown to improve survival.

Conditions

• Nasopharyngeal Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Chemo + Low dose RT	Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1, Cisplatin 75mg/m2 IV D1.Radiathion therapy (LDFRT) using 50 cGy of radiation per fraction BID on the day of chemotherapy and the day after during induction i.e. 50 cGy x 4 times per cycle given for total of 2 cycles every 21 days.
DRUG	Chemo alone	Chemo alone: Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1 and Cisplatin (CDDP) 75mg/m2 IV D1 given for 2 cycles every 21 days.

Timeline

• Start date: 2012-10-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2019-03-26
• Last updated: 2019-03-26