A Study of High-Risk Oral Cavity Cancer

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.

Conditions

• Oral Cavity Cancer

Interventions

DRUG

Thalidomide, Celebrex

Immediately after operation starts thalidomide (50) 4# per day and celecoxib (Celebrex)(200) 2# bid for three weeks, in addition to standard postoperative concurrent chemoradiotherapy

DRUG

Cyclophosphamide, Dexamethasone

Immediately after operation starts cyclophosphamide (50) 1# per day and dexamethasone (0.5) 2# qd for three weeks, in addition to standard postoperative concurrent chemoradiotherapy

Sponsors & Collaborators

• National Taiwan University Hospital

  collaborator OTHER

• Chang Gung Memorial Hospital

  collaborator OTHER

• Mackay Memorial Hospital

  collaborator OTHER

• Changhua Christian Hospital

  collaborator OTHER

• Sun Yat-sen University

  collaborator OTHER

• National Cheng-Kung University Hospital

  collaborator OTHER

• Kaohsiung Veterans General Hospital.

  collaborator OTHER

• Buddhist Tzu Chi General Hospital

  collaborator OTHER

• Chi Mei Medical Hospital

  collaborator OTHER

• National Health Research Institutes, Taiwan

  lead OTHER

Principal Investigators

• Ruey-Long Hong, MD, PhD. · Department of Oncology, National Taiwan University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-06-30

Primary Completion

2012-12-31

Completion

2012-12-31