A Phase II Study of Tegafur-Uracil as Maintenance Chemotherapy in Patients With Stage II of Colon Cancer
|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: NCT02887365|
Recruitment Status : Unknown
Verified September 2016 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : September 2, 2016
Last Update Posted : September 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|MSI-L/MSS Stage II Colon Cancer||Drug: tegafur-uracil||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Tegafur-Uracil as Maintenance Chemotherapy in Patients With Stage II Microsatellite-Stable or Low-Level Microsatellite-Instability Colon Cancer|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||August 2017|
tegafur-uracil treatment in patients with stage II MSI-L or MSS colon cancer
No Intervention: Observation
Observation for one year
- 3-year disease-free survival Safety profile of tegafur-uracil [ Time Frame: 3 years ]
To observed safety profile of tegafur-uracil as maintenance chemotherapy in patients with stage II microsatellite- stable or low-level microsatellite -instability colon cancer.
The hematological and biochemistry test should be closely monitored during the treatment period because of bone marrow depression, liver dysfunction, dehydration, anorexia, nausea, vomiting, and other adverse reactions have reported in clinical treatment. The evaluation would be included the date or symptoms that the package insert have mentioned.
- 5-year overall survival [ Time Frame: 3 years ]3-year disease free survival (DFS) rate CT/MRI scan will be performed within 28 days prior to treatment, and then every 4 months from the start of treatment for the 1st year, then every half year for the 2nd year, and every year for the 3rd to 5th year. DFS will be measured from the start date of study treatment to the date of disease recurrence. 5-year overall survival (OS) rate OS will be measured from the start date of study treatment to the date of death.
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): NCT02887365
|Contact: Been Ren Lin, Ph.Demail@example.com|
|National Taiwan University Hospital||Recruiting|
|Contact: Been Ren Lin 886-972651798 firstname.lastname@example.org|
|Principal Investigator:||Been Ren Lin, Ph.D||National Taiwan University Hospital|