NCT00201279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 1999

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 20, 2005

Status Verified

January 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Oral CavitySquamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Primary tumor recurrence

Secondary Outcomes (1)

  • The development of a second primary tumor

Interventions

13-cis Retino AcidDRUG

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Study Officials

  • Mow-Ming Hsu, MD

    National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

April 1, 1999

Study Completion

September 1, 2012

Last Updated

September 20, 2005

Record last verified: 2005-01

Locations

TW(1)