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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by National Health Research Institutes, Taiwan.
Recruitment status was  Recruiting
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:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00933387
First received: July 3, 2009
Last updated: October 29, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Oral Cancer
Drug: Cetuximab,Paclitaxel,Cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • The primary endpoint is the overall response rate after completion of the assigned treatment. [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 47
Study Start Date: September 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933387

Contacts
Contact: B R Chen, RN, BS 886-2-26534401 ext 25162 brong@nhri.org.tw

Locations
Taiwan
National Health Research of Institutes, Taiwan Cooperative Oncology Group Recruiting
Tainan, Taiwan
Principal Investigator: S T Tsai, MD         
Principal Investigator: W S Hwang, BS         
Principal Investigator: C J Tsao, MD         
Principal Investigator: C C Chen, MD         
Principal Investigator: K Y Tsai, MD         
Principal Investigator: C F Chiu, MD         
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
Principal Investigator: J Y Chang, M.D. National Health Research of Institutes
  More Information

No publications provided

Responsible Party: Chen, Bor-rong / Research Nurse, National Health Research Institutes/Taiwan Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00933387     History of Changes
Other Study ID Numbers: T1309, EMR62202-845
Study First Received: July 3, 2009
Last Updated: October 29, 2009
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Health Research Institutes, Taiwan:
oral squamous cell carcinoma
neoadjuvant bio-chemotherapy
concurrent bio-radiotherapy
biomarker

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Mouth Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Cetuximab
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 22, 2014