Overview

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