Chemoprevention Study of Oral Cavity Squamous Cell Carcinoma

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study the effect of 13-cis retinoic acid in preventing second primary malignancy in the oral cavity cancer patients after curative local treatment and to study the toxicity and compliance of 13-cis retinoic acid.

• Phase: 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; China Medical University Hospital; Koo Foundation Sun Yat-Sen Cancer Center; Mackay Memorial Hospital; National Cheng-Kung University Hospital; National Taiwan University Hospital; Sun Yat-sen University; Taichung Veterans General Hospital

Criteria

Inclusion Criteria:

• Clinically free of disease after having undergone surgery for histologically confirmed primary SCC of the oral cavity(Buccal mucosa +Oral tongue )

• Without any risk factor of recurrence listed below:

• Nodal extracapsular spread of disease (ECS)

• Number of positive node > 2

• Perineural involvement

• Lymphovascular emboli/permeation in resected surgical specimen

• Histologically positive surgical margins, but no gross residual disease

Exclusion Criteria:

• A KPS of less than 50 percent

• Serum creatinine and/or GOT/GPT greater than 2 times upper normal limit

• Distant metastasis

• Has previously received chemotherapy

• Has received within the two years diagnosis of any cancer

• Women of reproductive capacity

• Cases beyond the age range of 20-65 years.