Clinical trial NCT00933387: A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Cancer
Keywords: oral squamous cell carcinoma
neoadjuvant bio-chemotherapy
concurrent bio-radiotherapy
biomarker
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: China Medical University Hospital
name: National Cheng-Kung University Hospital
name: Chi Mei Medical Hospital
name: Changhua Christian Hospital
name: Chang Gung Memorial Hospital
First posted: 2009-07-07
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The primary endpoint is the overall response rate after completion of the assigned treatment.
timeFrame: 18 weeks
Secondary outcomes:
measure: Secondary endpoints include the response rate after neoadjuvant therapy, progression-free survival, overall survival, biomarker prediction, and toxicity.
timeFrame: >2 years
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Health Research of Institutes, Taiwan Cooperative Oncology Group
Study officials:
affiliation: National Health Research of Institutes
name: J Y Chang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: