We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborators:
China Medical University Hospital
National Cheng-Kung University Hospital
Chi Mei Medical Hospital
Changhua Christian Hospital
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Oral Cancer Drug: Cetuximab,Paclitaxel,Cisplatin Phase 2

Detailed Description:
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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : September 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: open label
an open-labelled, single-arm
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The primary endpoint is the overall response rate after completion of the assigned treatment. [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. Secondary endpoints include the response rate after neoadjuvant therapy, progression-free survival, overall survival, biomarker prediction, and toxicity. [ Time Frame: >2 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933387


Locations
Layout table for location information
Taiwan
National Health Research of Institutes, Taiwan Cooperative Oncology Group
Tainan, Taiwan
Sponsors and Collaborators
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
Investigators
Layout table for investigator information
Principal Investigator: J Y Chang, M.D. National Health Research of Institutes
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT00933387    
Other Study ID Numbers: T1309
EMR62202-845
First Posted: July 7, 2009    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: October 2009
Keywords provided by National Health Research Institutes, Taiwan:
oral squamous cell carcinoma
neoadjuvant bio-chemotherapy
concurrent bio-radiotherapy
biomarker
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Mouth Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
 Stomatognathic Diseases
Paclitaxel
Cetuximab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological