A Study of High-Risk Oral Cavity Cancer

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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 compliance of post-operative anti-angiogenesis therapy

Study design:

This is a multi-center randomized controlled phase II/III two-stage study.

Study endpoints:

The primary endpoint is the tumor-free survival (primary and second primary malignancies) and the primary analysis is to compare the tumor-free survival between groups.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Collaborators: Buddhist Tzu Chi General Hospital; Chang Gung Memorial Hospital; Changhua Christian Hospital; Chi Mei Medical Hospital; Kaohsiung Veterans General Hospital.; Mackay Memorial Hospital; National Cheng-Kung University Hospital; National Taiwan University Hospital; Sun Yat-sen University
• Treatments: BB 1101; Celecoxib; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Thalidomide

Criteria

Inclusion Criteria:

1. Histologically proved oral cavity squamous cell carcinoma (buccal and mobile tongue).

2. Clinical stage T4a with skin involvement or resectable N2-3 by UICC/AJCC 1997 staging system.(24)

3. Curative-intent operation feasible and arranged.

4. Eastern Cooperative Oncology Group performance status ≦ 1.

5. A leukocyte count ≧3750/μL, Hb ≧10 g/dL, and a platelet count ≧100,000/μL.

6. A serum bilirubin level < 1.5 UNL (upper normal limit), serum creatinine level < 1.5 UNL or creatinine clearance > 60 mL/min.

7. Age less than 70 years old

8. Informed consent signed.

Exclusion Criteria:

1. Evidence of distant metastatic.

2. Presence of another malignancy other than treated squamous/basal cell carcinoma of the skin.

3. Presence of uncontrolled hypertension, poorly controlled heart failure.

4. Presence of active infection.

5. Patients who have been or are being treated with chemotherapy, radiotherapy, immunotherapy, or other experimental therapies.

6. 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.