Identifying Prognostic Factors in Patients Receiving Tega... | NCT00898846

NCT00898846

ID	Type	Description	Link
TMDU-BRI-CC-05-02

Status Module

Sponsor/Collaborators Module

Name	Class
Tokyo Medical and Dental University	OTHER

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UFT adjuvant therapy group		UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year. During protocol treatment, clinical findings and laboratory values are evaluated every month. After the completion of protocol treatment, patients are followed-up, according to the schedule defined in the study protocol, for 5 years until recurrence, other malignancy or death is confirmed.	Drug: UFT adjuvant chemotherapy
Observation group		Patients are followed-up without adjuvant treatment, according to the schedule defined in the study protocol, for 5 years until recurrence, other malignancy or death is confirmed.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UFT adjuvant chemotherapy	Drug	UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mRNA levels	mRNA levels of patients are analyzed by the Danenberg tumor profile (DTP) method in the following indicators: thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD), thymidine phosphorylase (TP), orotate phosphoribosyltransferase (OPRT), folylpolyglutamate synthetase (FPGS) vascular endothelial growth factor (VEGF), and cyclooxygenase-2 (Cox-2) mRNA levels.	9years

Secondary Outcomes

Measure	Description	Time Frame
Analysis of microsatellite instability (MSI) and chromosomal instability (CIN)	MSI and CIN (i.e., 18q LOH) are analyzed using paraffin embedded samples.	At enrollment
Histopathological examination

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Kenichi Sugihara, MD, PhD	Tokyo Medical and Dental University	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Nagoya Ekisaikai Hospital		Nagoya	Aichi-ken	454-8502	Japan
Ban Buntane Houtokukai Hospital

References Module

No data available