Status:
TERMINATED
A Study of High-Risk Oral Cavity Cancer
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
National Taiwan University Hospital
Chang Gung Memorial Hospital
Conditions:
Oral Cavity Cancer
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE2
PHASE3
Brief Summary
Objectives: 1. To study the effect of anti-angiogenesis therapy on reducing the recurrence of high-risk oral cavity cancer patients after curative local treatment. 2. To study the toxicity and compli...
Detailed Description
Type and number of patients: Patients with resectable oral cancer of clinical stage N2, 3 or skin-involved T4 will be enrolled. Sample size at the first stage is 64 patients per group and the total ...
Eligibility Criteria
Inclusion
- Histologically proved oral cavity squamous cell carcinoma (buccal and mobile tongue).
- Clinical stage T4a with skin involvement or resectable N2-3 by UICC/AJCC 1997 staging system.(24)
- Curative-intent operation feasible and arranged.
- Eastern Cooperative Oncology Group performance status ≦ 1.
- A leukocyte count ≧3750/μL, Hb ≧10 g/dL, and a platelet count ≧100,000/μL.
- A serum bilirubin level \< 1.5 UNL (upper normal limit), serum creatinine level \< 1.5 UNL or creatinine clearance \> 60 mL/min.
- Age less than 70 years old
- Informed consent signed.
Exclusion
- Evidence of distant metastatic.
- Presence of another malignancy other than treated squamous/basal cell carcinoma of the skin.
- Presence of uncontrolled hypertension, poorly controlled heart failure.
- Presence of active infection.
- Patients who have been or are being treated with chemotherapy, radiotherapy, immunotherapy, or other experimental therapies.
- Women who test positive for pregnancy. Note: Patients received neck lymph node biopsy will be eligible and the stage will be given according to the preoperative status.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00934739
Start Date
June 1 2007
End Date
December 1 2012
Last Update
February 25 2015
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