Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma

A Randomized Phase III Non-inferiority Study of Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma

This is a Phase III trial to study the effectiveness of nedaplatin versus cisplatin with IMRT chemoradiotherapy in treating patients with locoregionally advanced nasopharyngeal carcinoma.

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.

Inclusion Criteria:

• Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
• Original clinical staged as T1-4N1-3 or T3-4N0（according to the 7th AJCC edition）
• No evidence of distant metastasis (M0)
• Male and no pregnant female
• Age between 18-65
• WBC ≥ 4,000/mm3 and PLT ≥ 100,000/mm3
• With normal liver function test (ALT、AST ≤ 2.5×ULN)
• With normal renal function test (Creatinine ≤ 1.5×ULN)
• Satisfactory performance status: Karnofsky scale (KPS)> 70
• Without radiotherapy or chemotherapy
• Patients must give signed informed consent

Exclusion Criteria:

• Patients have evidence of relapse or distant metastasis
• The presence of uncontrolled life-threatening illness
• Receiving other ways of anti-cancer therapy
• Receiving radiotherapy or chemotherapy
• Pregnancy or lactation