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

Phase 3
20 Years
65 Years
Not Enrolling
Oral Cavity, Squamous Cell Carcinoma

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Trial Information

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

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Primary tumor recurrence

Principal Investigator

Mow-Ming Hsu, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

April 1999

Completion Date:

September 2012

Related Keywords:

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