drugset / Trial / NCT00934739
A Study of High-Risk Oral Cavity Cancer
Phase 2/3
Terminated
150 enrolled
National Health Research Institutes, Taiwan
Buddhist Tzu Chi General Hospital · collabChang Gung Memorial Hospital · collabChanghua Christian Hospital · collabChi Mei Medical Hospital · collabKaohsiung Veterans General Hospital. · collabMackay Memorial Hospital · collabNational Cheng-Kung University Hospital · collabNational Taiwan University Hospital · collabSun Yat-sen University · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-06
- Primary completion
- 2012-12
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Celecoxib | Other / unclassified | 200 unknown | — |
| Comparator | Cyclophosphamide | Other / unclassified | 50 unknown | — |
| Comparator | Dexamethasone | Small molecule | 0.5 unknown | — |
| Subject | Thalidomide | Other / unclassified | 50 unknown | — |