Chemoprevention Study of Oral Cavity Squamous Cell Carcinoma
NCT ID: NCT00201279
Last Updated: 2005-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
342 participants
INTERVENTIONAL
1999-04-30
2012-09-30
Brief Summary
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Detailed Description
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Second primary malignancies occur at a constant annual rate of 5% to 7% in all head and neck cancer patients1. Furthermore, because the mortality from primary disease recurrence plateaus after 2 to 3 years in patients with locally advanced disease, second primary tumors become the major cause of late cancer mortality.
Sporn et al defined chemoprevention as an effort to arrest or reverse premalignant cells during their progression to invasive malignancy2,3. The concept of chemoprevention has evolved to include the use of specific compounds, rather than general dietary changes, to prevent the development of cancer.
Hong et al studied the effects of 13-cis retinoic acid on patients with history of head and neck cancers 4. After treatment of head and neck primary cancers with either radiotherapy or surgery or both, 103 patients were randomized to receive either adjuvant 13-cis retinoic acid or placebo. In an update of this trial with 55 months of follow-up, 16 patients (31%) in the placebo group had developed second primary tumors, whereas 7 patients (14%) in the treatment group had developed second primary tumors (p=0.04) 5. Betel quid chewing becomes increasingly popular in Taiwan. Exposure to both smoking and betel quid significantly increases the risk of oral cavity cancer6. The hazard of developing second primary tumors is high in this population, therefore, chemoprevention is worthy of trial.
Use of 13-cis RA for chemoprevention of head and neck cancer only has been published by Hong et al. Their cases included a variety of head and neck cancers that are known to be not a homogenous group. The risk of second primary is different for different primary sites. Therefore, the value of 13-cis RA in chemoprevention is not conclusively addressed. In our proposal, only oral cavity cancer is included and the result will be more convincing. The result could be the basis of further chemoprevention clinical trial or guideline for clinical practice.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Interventions
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13-cis Retino Acid
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
65 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Changhua Christian Hospital
OTHER
China Medical University Hospital
OTHER
Buddhist Tzu Chi General Hospital
OTHER
Taichung Veterans General Hospital
OTHER
Mackay Memorial Hospital
OTHER
Chang Gung Memorial Hospital
OTHER
Koo Foundation Sun Yat-Sen Cancer Center
OTHER
Chi Mei Medical Hospital
OTHER
National Cheng-Kung University Hospital
OTHER
National Health Research Institutes, Taiwan
OTHER
Principal Investigators
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Mow-Ming Hsu, MD
Role: STUDY_CHAIR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Related Links
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Related Info
Other Identifiers
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T1399
Identifier Type: -
Identifier Source: org_study_id