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TPF Induction Chemotherapy for Locally Advanced and Resectable Oral Squamous Cell Carcinoma

NCT01542931 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2017-08-21

No results posted yet for this study

Summary

Induction chemotherapy is regarded as an effective way to reduce or downgrade the locally advanced or aggressive cancers, and to improve the chance of eradication of the locoregional lesions by radical surgery and/or radiotherapy. However, there are still debates on the clinical value of induction chemotherapy for patients with advanced and resectable oral squamous cell carcinoma. The hypothesis of this study is that the induction chemotherapy of TPF (docetaxel, cisplatin, and 5-fluorouracil) protocol could benefit the patients with locally advanced oral squamous cell carcinoma. The endpoints of this study are the survival rate, local control, and safety.

Conditions

  • Stage III Oral Cavity Squamous Cell Carcinoma
  • Stage IVA Oral Cavity Squamous Cell Carcinoma

Interventions

DRUG

TPF induction chemotherapy

Docetaxel (at a dose of 75mg/m2 of body surface area) was administered as a 2-hour intravenous infusion, followed by intravenous cisplatin (75 mg/m2), administered during a period of 2 to 3 hours. After completion of the cisplatin infusion, 5-Fu (750 mg/m2/day) was administered during a period at least 8 hours for 5 days. Induction chemotherapy was given every 3 weeks for 2 cycles, unless there was disease progression, unacceptable toxic effects, or withdrawal of consent by the patient.

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Zhi-yuan Zhang, MD, PhD · Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong 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
2008-01-31
Primary Completion
2015-12-31
Completion
2015-12-31

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 NCT01542931 on ClinicalTrials.gov