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Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC)

NCT00817583 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2009-01-27

No results posted yet for this study

Summary

The primary objective of this study is to determine the response rate, tolerance and overall survival in patients with stage III, IVa, IVb NPC treated with neoadjuvant chemotherapy (TPF regimen) and concurrent chemoradiation.

Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage III,IVa, IVb NPC treated with this regimen.

The third objective of this study is to evaluate who may benifit from this treatment regimen.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

docetaxel, cisplatin, fluorouracil

neoadjuvant chemotherapy:docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. concurrent chemotherapy:cisplatin 40 mg/m2 weekly

RADIATION

3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • XiaoShen WANG, M.D. · Department of Radiation Oncology, Cancer Hospital, Fudan University

  • ChaoSu HU, M.D. · Department of Radiation Oncology, Cancer Hospital, Fudan University

  • ChunYing Shen, M.D. · Department of Radiation Oncology, Cancer Hospital, Fudan University

  • HongMei Ying, M.D. · Department of Radiation Oncology, Cancer Hospital, Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-07-31
Completion
2011-07-31

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 NCT00817583 on ClinicalTrials.gov