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Neo-adjuvant Erbitux-based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer

NCT01440270 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2020-05-05

No results posted yet for this study

Summary

Epidermal growth factor receptor（EGFR） is a potential target for new anticancer therapy in head and neck squamous cell carcinoma, because blocking the EGFR by a monoclonal antibody results in inhibition of the stimulation of the receptor, therefore, in inhibition of cell proliferation, enhanced apoptosis, and reduced angiogenesis, invasiveness and metastases. The study hypothesis is that neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy for locally advanced oral/oropharyngeal cancer could benefit the patients on prognosis. The endpoints of this study are the pathological complete response after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy, the survival rate, and the safety.

Conditions

  • Locally Advanced Malignant Neoplasm
  • Oral Cancer
  • Oropharyngeal Carcinoma

Interventions

DRUG

Neo-adjuvant Erbitux-based chemotherapy

Name/Substance: Erbitux Formulation: 2 mg/ml or 5 mg/ml Dose: 400 mg/m\^2 initial, and then 250 mg/m\^2 weekly Route: Intravenous infusion Frequency \& treatment mode: Weekly Duration: 6 weeks Name/Substance: Docetaxel Formulation: Liquid (20 mg/2 ml) Dose: 75 mg/m\^2 Route: Intravenous infusion Frequency \& treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks) Name/Substance: Cisplatin Formulation: Powder (30 mg) Dose: 75 mg/m\^2 Route: Intravenous infusion Frequency \& treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks) Arms: Neo-adjuvant Erbitux-based chemotherapy

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Tongji University

    collaborator OTHER

  • Second Military Medical University

    collaborator OTHER

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Chen-ping Zhang, MD, PhD · Department of Oral and Maxillofacial Surger, Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-10-31
Completion
2017-02-28

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 NCT01440270 on ClinicalTrials.gov