Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma

• Progress-free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
  
  

• Determine the toxic effects, both quantitatively and qualitatively, and quality of life (QoL) of these regimens in these patients. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  Administration and Monitoring Patients will be evaluated in the clinic and eligibility and informed consent obtained. Patients will be monitored for clinical toxicity by standard NIH criteria. QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) and EORTC QLQ Head and Neck. A time period of 4 weeks will constitute the time for clinical safety monitoring.
  
  
• Complete Response (CR) [ Time Frame: after the completion of the chemoradiotherapy treatment (up to 9 weeks) ] [ Designated as safety issue: No ]
  CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.
  
  
• Overall Survival(OS) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
  
  
• Locoregional Relapse-Free Survival(LRRFS) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.
  
  
• Distant Metastasis-Free Survival (DMFS) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
  
  

Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was superior to radiotherapy alone in the treatment of locoregionally advanced NPC. Cisplatin-based chemotherapy has been shown to have higher response rates in NPC than noncisplatin regimens. However, the patients' compliance was unsatisfactory because the obvious gastrointestinal toxicity of cisplatin. Nedaplatin is the new second generation platinum and it has slight gastrointestinal reaction. Our trial is in order to study the effectiveness of nedaplatin or cisplatin with intensity-modulated radiation therapy (IMRT) chemoradiotherapy in treating patients with locoregionally advanced NPC.