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Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma

NCT01536223 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2013-03-05

No results posted yet for this study

Summary

Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy with concurrent chemoradiation.

Conditions

  • Chemoradiation
  • Nasopharyngeal Carcinoma

Interventions

DRUG

PF (cisplatin and 5-fluorouracil) group

the group the patients using PF(cisplatin and 5-fluorouracil )neoadjuvant chemotherapy 3 cycles of neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 100mg/m2 and 5-fluorouracil 4000mg/m2 civ 120 hours And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2.

DRUG

TPF (docetaxel plus cisplatin and 5-fluorouracil) group

3 cycles of TPF neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2,cisplatin75mg/m2 and 5-fluorouracil 2400mg/m2 civ 96 hours . And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER

  • Zhejiang University

    collaborator OTHER

  • Zhejiang Provincial People's Hospital

    collaborator OTHER

  • Sir Run Run Shaw Hospital

    collaborator OTHER

  • Wenzhou Medical University

    collaborator OTHER

  • Zhejiang Cancer Hospital

    lead OTHER

Principal Investigators

  • Xiaozhong Chen, MD · Zhejiang Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-12-31
Completion
2015-02-28

Countries

  • China

Study Locations

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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 NCT01536223 on ClinicalTrials.gov