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

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Brief Title

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)

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

The primary endpoint is the overall response rate after completion of the assigned treatment.

Secondary Outcome

 Secondary endpoints include the response rate after neoadjuvant therapy, progression-free survival, overall survival, biomarker prediction, and toxicity.

Condition

Oral Cancer

Intervention

Cetuximab,Paclitaxel,Cisplatin

Study Arms / Comparison Groups

 open label
Description:  an open-labelled, single-arm

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

47

Start Date

September 2009

Completion Date

November 2013

Primary Completion Date

July 2011

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

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

J Y Chang, M.D., ,

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations

NCT ID

NCT00933387

Organization ID

T1309

Secondary IDs

EMR62202-845

Responsible Party

Sponsor

Study Sponsor

National Health Research Institutes, Taiwan

Collaborators

 China Medical University Hospital

Study Sponsor

J Y Chang, M.D., Principal Investigator, National Health Research of Institutes

Verification Date

October 2009