Clinical trial · Interventional
Chemoprevention Study of Oral Cavity Squamous Cell Carcinoma
Phase III Placebo-Controlled Chemoprevention Study of Oral Cavity Squamous Cell Carcinoma Patients
NCT00201279CI-TRIAL-00000169completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cavity | — | UNRESOLVED | — |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 13-cis Retino Acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Primary tumor recurrence
Secondary outcomes (1)
- measure
- The development of a second primary tumor
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.