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

Phase 2

Completed

• Conditions: Oral Cancer
• Interventions: Drug: Cetuximab,Paclitaxel,Cisplatin

• Registration Number: NCT00933387
• Lead Sponsor: National Health Research Institutes, Taiwan

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.

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 Timeline

• Study First Submitted: 2009-07-03
• Study First Submitted QC: 2009-07-06
• Study First Posted: 2009-07-07
• Study Start: 2009-09
• Status Verified: 2009-10
• Primary Completion: 2011-07
• Study Completion: 2013-11
• Last Update Submitted: 2016-05-03
• Last Update Posted: 2016-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
open label	Cetuximab,Paclitaxel,Cisplatin	an open-labelled, single-arm

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the overall response rate after completion of the assigned treatment.	18 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints include the response rate after neoadjuvant therapy, progression-free survival, overall survival, biomarker prediction, and toxicity.	>2 years

Trial Locations

Locations (1)

National Health Research of Institutes, Taiwan Cooperative Oncology Group; 🇨🇳 Tainan, Taiwan