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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
History of Changes

July 3, 2009
October 29, 2009
September 2009
March 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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)
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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
47
March 2013
March 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
Both
18 Years to 70 Years
No
Contact: B R Chen, RN, BS 886-2-26534401 ext 25162 brong@nhri.org.tw
Taiwan
 
NCT00933387
T1309, EMR62202-845
Yes
Chen, Bor-rong / Research Nurse, National Health Research Institutes/Taiwan Cooperative Oncology Group
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