Nedaplatin Combined With Gemcitabine in the Treatment of Recurrent and/or Metastatic Nasopharyngeal Carcinoma : a Single Arm and Phase Ⅱ Clinical Trail

Phase 2

Terminated

• Conditions: Recurrent and Metastatic Nasopharyngeal Carcinoma
• Interventions: Drug: nedaplatin and gemcitabine

• Registration Number: NCT02789189
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of nedaplatin combined with gemcitabine in the treatment of recurrent and metastatic nasopharyngeal carcinoma

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-05
• Study First Submitted: 2016-05-29
• Study First Submitted QC: 2016-05-29
• Study Start: 2016-06
• Study First Posted: 2016-06-02
• Primary Completion: 2019-09-04
• Last Update Submitted: 2019-09-04
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• biopsy proved nasopharyngeal carcinoma; stage IVc according to Union for International Cancer Control (UICC) edition VII,or recurrent disease after chemotherapy and/or radiotherapy; 18 years or older; without other malignancy; proper functioning of the major organs.

Exclusion Criteria

• allergic to nedaplatin and/or gemcitabine; female within gestation period or lactation; patients received drug of other clinical trail within 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nedaplatin combined with gemcitabine	nedaplatin and gemcitabine	-

Primary Outcome Measures

Name	Time	Method
overall survival	5 years