Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201279
Status:
COMPLETED
Last Update Posted:
2005-09-20
First Post:
2005-09-13
Brief Title:
Chemoprevention Study of Oral Cavity Squamous Cell Carcinoma
Sponsor:
National Health Research Institutes Taiwan
Organization:
National Health Research Institutes Taiwan
Study Overview
Official Title:
Phase III Placebo-Controlled Chemoprevention Study of Oral Cavity Squamous Cell Carcinoma Patients
Status:
COMPLETED
Status Verified Date:
2005-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 malignancy23 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 p004 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
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 malignancy23 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 p004 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None