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)
Recruitment status was Recruiting
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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) |
- The primary endpoint is the overall response rate after completion of the assigned treatment. [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
- 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 |
Inclusion Criteria:
- High-risk, locally advanced (TxN2b~3 or unresectable T4, M0) OSCC
- Histologically confirmed squamous cell carcinoma
- Performance status: Eastern Cooperative Oncology Group performance status (ECOG) 0-1
- age 18 years or older, less than 70 years of age
- Having signed informed consent
- Measurable disease by CT or MRI
- Adequate hematologic, hepatic and renal function
Exclusion Criteria:
- Prior radiotherapy for targeted lesions, chemotherapy, EGFR pathway targeting therapy
- Prior surgery for cancer except for the purpose of diagnostic biopsy
- 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
- Concomitant anticancer therapies within the past 28 days
- Severe cardiopulmonary diseases and other systemic disease under poor control
- Uncontrolled chronic neuropathy
- Women who are positive of pregnancy, or in breast-feeding
- Known allergy to any study treatment
- Legal incapacity
- Significant disease which, in the investigator's opinion, would exclude the patient from the study
Contacts and Locations| Contact: B R Chen, RN, BS | 886-2-26534401 ext 25162 | brong@nhri.org.tw |
| 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 | |
| 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 May 23, 2013