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Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

NCT01872962 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2018-04-24

No results posted yet for this study

Summary

The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy (CCRT) with CCRT alone in patients with locoregionally advanced nasopharyngeal carcinoma(NPC), in order to confirm the value of induction chemotherapy in NPC patients.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

gemcitabine and cisplatin (Induction chemotherapy)

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.

RADIATION

IMRT and concurrent cisplatin

Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor, concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • Peking University

    collaborator OTHER

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • First People's Hospital of Foshan

    collaborator OTHER

  • Cancer Hospital of Guangxi Medical University

    collaborator OTHER

  • Jiangxi Provincial Cancer Hospital

    collaborator OTHER

  • Xijing hospital of The fourth military medical university

    collaborator UNKNOWN

  • Cancer Hospital of Guizhou Province

    collaborator OTHER

  • Affiliated Cancer Hospital of Shantou University Medical College

    collaborator OTHER

  • Fifth Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jun Ma, M.D. · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2018-11-30
Completion
2020-11-30

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 NCT01872962 on ClinicalTrials.gov