Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Guangzhou Medical University; Meizhou City Hospital Of Guangdong Provience; The First Affiliated Hospital of Guangdong Pharmaceutical University
• Treatments: Cisplatin; Nedaplatin

Criteria

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