Trial | NCT01540136  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    402
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.
Study Started
Feb 29
2012
Primary Completion
May 31
2014
Study Completion
Jul 31
2016
Last Update
Oct 28
2016
Estimate

Drug Nedaplatin

Nedaplatin 100mg/m2(3 weekly),D1,D22,D43 of RT

  • Other names: NDP

Drug Cisplatin

Cisplatin 100mg/m2(3 weekly),D1,D22,D43 of RT

  • Other names: DDP

Cisplatin Active Comparator

Cisplatin combine with IMRT

Nedaplatin Experimental

Nedplatin combine with IMRT

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
No Results Posted