Status:
COMPLETED
Chemoprevention Study of Oral Cavity Squamous Cell Carcinoma
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
National Taiwan University Hospital
Changhua Christian Hospital
Conditions:
Oral Cavity
Squamous Cell Carcinoma
Eligibility:
All Genders
20-65 years
Phase:
PHASE3
Brief 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 toxi...
Detailed Description
There are more than one thousand deaths annually from head and neck cancer in Taiwan (excluding nasopharyngeal carcinoma) and the majority of treatment failures are related to recurrence of primary di...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 1999
Trial Type :
INTERVENTIONAL
End Date :
September 1 2012
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT00201279
Start Date
April 1 1999
End Date
September 1 2012
Last Update
September 20 2005
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100