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Efficacy and Safety of TC+AVASTIN Versus TC in Patients With Metastatic Nasopharyngeal Carcinoma

NCT02250599 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-12-30

No results posted yet for this study

Summary

The present study will be a randomized, control, multicenter phase II study of metastatic nasopharyngeal carcinoma (NPC) treated with evacizumab (AVASTIN,Roch) with paclitaxel and carboplatin regimen (TC+AVASTIN) or carboplatin/paclitaxel alone (TC). The population consists of metastatic nasopharyngeal carcinoma (NPC) that failed the radical radiotherapy or chemotherapy-naïve advanced NPC (stage IV). The effectiveness and side effects will be evaluated according to RECIST 1.1 and NCI-CTC AE V4.0.TEORTC QLQ-C30 and EORTC QLQ-H\&N35 are used to measure PRO outcome for this study.

Conditions

  • Nasopharyngeal Neoplasms

Interventions

DRUG

Paclitaxel

Paclitaxel 175 mg/m2 IV Day 1 each 3-week cycle

DRUG

Bevacizumab

Bevacizumab 7.5 mg/kg Day 1 each 3-week cycle

DRUG

Carboplatin

Carboplatin AUC 6 IV Day 1 each 3-week cycle

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • li zhang, MD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-04-30
Completion
2016-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02250599 on ClinicalTrials.gov