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NCT Number: NCT00933387

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

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.

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Key information

Conditions

Oral Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Health Research of Institutes, Taiwan Cooperative Oncology Group

Tainan, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetuximab,Paclitaxel,Cisplatin

Drug

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

Primary outcomes

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

    Time frame: 18 weeks

Secondary outcomes

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

    Time frame: >2 years

Sponsors and collaborators

Lead sponsor

National Health Research Institutes, Taiwan

Other

Collaborators

  • Chang Gung Memorial Hospital
  • Changhua Christian Hospital
  • Chi Mei Medical Hospital
  • China Medical University Hospital
  • National Cheng-Kung University Hospital

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Jul 7, 2009
Registry last updated
May 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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