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A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00933387
Recruitment Status : Completed
First Posted : July 7, 2009
Last Update Posted : May 4, 2016
Information provided by (Responsible Party):

July 3, 2009
July 7, 2009
May 4, 2016
September 2009
July 2011   (Final data collection date for primary outcome measure)
The primary endpoint is the overall response rate after completion of the assigned treatment. [ Time Frame: 18 weeks ]
Same as current
Complete list of historical versions of study NCT00933387 on ClinicalTrials.gov Archive Site
Secondary endpoints include the response rate after neoadjuvant therapy, progression-free survival, overall survival, biomarker prediction, and toxicity. [ Time Frame: >2 years ]
Same as current
Not Provided
Not Provided
A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma
A Phase II Study of Neoadjuvant Bio-chemotherapy With Cetuximab, Paclitaxel, and Cisplatin (CPC) Followed by Cetuximab-based Concurrent Bio-radiotherapy in High-risk Locally Advanced Oral Squamous Cell Carcinoma (OSCC)
Surgical resection followed by concurrent chemoradiotherapy is considered as the standard of care for locally advanced OSCC (LAOSCC). Although the treatment could provide prompt local control, but it is also associated with high incidence of distant failure. Systemic chemotherapy given either before (neoadjuvant) or after (adjuvant) definitive local treatment has been extensively evaluated to improve the clinical outcome in LAOSCC. Regimens of taxane/cisplatin-based combinations have been shown to improve the treatment outcome of patients with locally advanced head and neck squamous cell carcinoma (HNSCC) in neoadjuvant setting. Recently, cetuximab (Erbitux®), a monoclonal antibody against epidermal growth factor receptor (EGFR), has also been proven to be an efficient agent for advanced and/or refractory HNSCC with acceptable toxicity profiles. In current study, we shall evaluate the feasibility, efficacy and safety of a triplet bio-chemotherapy consisting of cetuximab, paclitaxel, and cisplatin followed by cetuximab-based concurrent bio-radiotherapy (CBRT) in patients with LAOSCC.
Patients with high-risk, locally advanced (TxN2b~3 or T4N0~3, M0) OSCC will be eligible. To detect an interested objective response rate (p1) of 80% versus a non-interested response (p0) rate of 60%, with an α and 1-β of 0.05 and 0.2, respectively (two-sided test), including the estimated dropout rate of 10%, a total of 47 patients will be recruited.
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Oral Cancer
Drug: Cetuximab,Paclitaxel,Cisplatin
Cetuximab 500 mg/m2 iv infusion (120 min for the 1st infusion, 90 min for the 2nd , and 60 min for the subsequent) Paclitaxel 120 mg/m2 3-hour iv infusion Cisplatin 50 mg/m2 2-hour iv infusion
Experimental: open label
an open-labelled, single-arm
Intervention: Drug: Cetuximab,Paclitaxel,Cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2013
July 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. High-risk, locally advanced (TxN2b~3 or unresectable T4, M0) OSCC
  2. Histologically confirmed squamous cell carcinoma
  3. Performance status: Eastern Cooperative Oncology Group performance status (ECOG) 0-1
  4. age 18 years or older, less than 70 years of age
  5. Having signed informed consent
  6. Measurable disease by CT or MRI
  7. Adequate hematologic, hepatic and renal function

Exclusion Criteria:

  1. Prior radiotherapy for targeted lesions, chemotherapy, EGFR pathway targeting therapy
  2. Prior surgery for cancer except for the purpose of diagnostic biopsy
  3. Concomitant active 2nd malignancies or disease-free of malignancies < 3 years before the study except adequately treated in situ cervical cancer, or non-melanoma skin cancer
  4. Concomitant anticancer therapies within the past 28 days
  5. Severe cardiopulmonary diseases and other systemic disease under poor control
  6. Uncontrolled chronic neuropathy
  7. Women who are positive of pregnancy, or in breast-feeding
  8. Known allergy to any study treatment
  9. Legal incapacity
  10. Significant disease which, in the investigator's opinion, would exclude the patient from the study
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
National Health Research Institutes, Taiwan
National Health Research Institutes, Taiwan
  • China Medical University Hospital
  • National Cheng-Kung University Hospital
  • Chi Mei Medical Hospital
  • Changhua Christian Hospital
  • Chang Gung Memorial Hospital
Principal Investigator: J Y Chang, M.D. National Health Research of Institutes
National Health Research Institutes, Taiwan
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP