Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Nedaplatin; Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01540136

Sun Yat-sen University

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 402 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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402 participants in 2 patient groups

Nedaplatin

Experimental group

Description:

Nedplatin combine with IMRT

Treatment:

Drug: Nedaplatin

Cisplatin

Active Comparator group

Description:

Cisplatin combine with IMRT

Treatment:

Drug: Cisplatin