Chemoprevention Study of Oral Cavity Squamous Cell Carcinoma

Squamous Cell Carcinoma Clinical Trial

Official title:

Phase III Placebo-Controlled Chemoprevention Study of Oral Cavity Squamous Cell Carcinoma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201279
• Other study ID #: T1399
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: April 1999
• Est. completion date: September 2012

Study information

• Verified date: January 2005
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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 disease. Only patients with early-stage disease have high cure rates, but they remain at risk for the development of second primary tumors.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Oral Cavity
• Squamous Cell Carcinoma

Intervention

Drug:
• 13-cis Retino Acid

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (11)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Buddhist Tzu Chi General Hospital, Chang Gung Memorial Hospital, Changhua Christian Hospital, Chi Mei Medical Hospital, China Medical University Hospital, Mackay Memorial Hospital, National Cheng-Kung University Hospital, National Taiwan University Hospital, Sun Yat-sen University, Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary tumor recurrence
Secondary	The development of a second primary tumor

External Links

•   Link