We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Chemoprevention Study of Oral Cavity Squamous Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00201279
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 20, 2005
Information provided by:

Study Description
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 toxicity and compliance of 13-cis retinoic acid.

Condition or disease Intervention/treatment Phase
Oral Cavity Squamous Cell Carcinoma Drug: 13-cis Retino Acid Phase 3

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 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 342 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Phase III Placebo-Controlled Chemoprevention Study of Oral Cavity Squamous Cell Carcinoma Patients
Study Start Date : April 1999
Estimated Study Completion Date : September 2012
Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Primary tumor recurrence

Secondary Outcome Measures :
  1. The development of a second primary tumor

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00201279

National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Taiwan University Hospital
Changhua Christian Hospital
China Medical University Hospital
Buddhist Tzu Chi General Hospital
Taichung Veterans General Hospital
Mackay Memorial Hospital
Chang Gung Memorial Hospital
Koo Foundation Sun Yat-Sen Cancer Center
Chi Mei Medical Hospital
National Cheng-Kung University Hospital
Study Chair: Mow-Ming Hsu, MD National Taiwan University Hospital
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00201279     History of Changes
Other Study ID Numbers: T1399
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 20, 2005
Last Verified: January 2005

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell