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Cisplatin Plus Docetaxel Versus Cetuximab, Cisplatin, and Docetaxel in Metastatic Nasopharyngeal Carcinoma

NCT02633176 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-12-17

No results posted yet for this study

Summary

This is a Phase Ⅲ randomized, controlled, multi-center, trial comparing cisplatin plus docetaxel to cetuximab, cisplatin, and docetaxel induction chemotherapy followed by concurrent chemoradiation in previously untreated patients metastatic nasopharyngeal carcinoma (mNPC) to determine whether the addition of cetuximab to induction chemotherapy and chemoradiation could improve therapeutic efficacy in mNPC, and investigate predictive and prognostic factors for mNPC.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

Cetuximab

400 mg/m\^2 intravenously on day 1,then 250 mg/m\^2 intravenously every week of each 21 day cycle for 6 cycles of induction chemotherapy.250 mg/m\^2 intravenously every week concurrent with radiotherapy.

DRUG

Cisplatin

75mg/m\^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.30 mg/m\^2 intravenously every week concurrent with radiotherapy.

DRUG

Docetaxel

75mg/m\^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.

DRUG

Capecitabine

1000mg/m\^2 orally twice a day, days 1 to 14 of each 21 day cycle for at least 2 years or until progression following concurrent chemoradiation.

RADIATION

Radiotherapy

60-66 Gy if complete response or 66-70 Gy if partial response following induction chemotherapy.

Sponsors & Collaborators

  • Chinese Southwest Oncology Group

    collaborator UNKNOWN

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Tongyu Lin, MD · Sun Yat-sen University

  • Taixiang Lu, MD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2023-01-31

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 NCT02633176 on ClinicalTrials.gov