Status:
COMPLETED
A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
China Medical University Hospital
National Cheng-Kung University Hospital
Conditions:
Oral Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 ...
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%...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00933387
Start Date
September 1 2009
End Date
November 1 2013
Last Update
May 4 2016
Active Locations (1)
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1
National Health Research of Institutes, Taiwan Cooperative Oncology Group
Tainan, Taiwan