Weekly Cisplatin or Nedaplatin Concurrent With Intensity-modulated Radiation Therapy in Nasopharyngeal Carcinoma

Phase 3

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Nedaplatin; Drug: Cisplatin

• Registration Number: NCT02301208
• Lead Sponsor: He Xia

Brief Summary

This is a randomized Phase III study to evaluate efficancy of weekly cisplatin or nedaplatin concurrent with Intensity-modulated radiation therapy in Nasopharyngeal Carcinoma (NPC).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-19
• Study First Submitted QC: 2014-11-21
• Study First Posted: 2014-11-25
• Status Verified: 2014-12
• Study Start: 2014-12
• Last Update Submitted: 2014-12-05
• Last Update Posted: 2014-12-08
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Pathologically confirmed untreated NPC patients
• T1-2N1-3M0 or T3-4NxM0
• 18-70 years old
• with MRI examinations
• ECOG ≤ 2
• With written consent

Exclusion Criteria

• With a second cancer
• Pregnancy
• With other severe diseases (blood,liver ,kidney or heart diseases)
• Could not be staged properly
• Without written consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose nedaplatin arm	Nedaplatin	concurrent chemotherapy: nedaplatin 30mg/m2,weekly,for 6 cycles during radiotherapy
High dose cisplatin arm	Cisplatin	concurrent chemotherapy: cisplatin 30mg/m2,weekly,for 6 cycles during radiotherapy
Low dose cisplatin arm	Cisplatin	concurrent chemotherapy: cisplatin 20mg/m2,weekly,for 6 cycles during radiotherapy
Low dose nedaplatin arm	Nedaplatin	concurrent chemotherapy: nedaplatin 20mg/m2,weekly,for 6 cycles during radiotherapy

Primary Outcome Measures

Name	Time	Method
Progress-free survival	2 years
Response rate	2 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 years
Tumor response	radiotherapy in 2 week、4 week、7 week