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

Oral Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933387
• Other study ID #: T1309
• Secondary ID: EMR62202-845
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2009
• Last updated: May 3, 2016
• Start date: September 2009
• Est. completion date: November 2013

Study information

• Verified date: October 2009
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Oral Cancer

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Health Research of Institutes, Taiwan Cooperative Oncology Group	Tainan

Sponsors (6)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Chang Gung Memorial Hospital, Changhua Christian Hospital, Chi Mei Medical Hospital, China Medical University Hospital, National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the overall response rate after completion of the assigned treatment.		18 weeks	Yes
Secondary	Secondary endpoints include the response rate after neoadjuvant therapy, progression-free survival, overall survival, biomarker prediction, and toxicity.		>2 years	Yes