Clinical Trial: A Phase II Study of Tegafur-Uracil as Maintenance Chemotherapy in Patients With Stage II of Colon Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: Investigators would like to assess the efficacy and safety of tegafur-uracil in patients with stage II MSI-L or MSS colon cancer under metronomic setting for one year.

Detailed Summary: Approximately 15% cases of colon cancer are associated a type of inherited susceptibility called defective DNA mismatch repair (MMR), which is frequently measured by either the presence of microsatellite instability (MSI) or by testing for loss of the protein products for genes involved in DNA MMR (MLH1, MSH2, MSH6 and PMS2). Tumors are classified according to the percentage of abnormal microsatellite regions present: >30-40% as high-level MSI (MSI-H), <30-40% as low-level MSI (MSI-L) and no abnormalities as microsatellite stable (MSS). In the condition of MSI presence, evidence shows that MSI is a marker of a more favorable survival outcome and a predictor of decreased benefit from adjuvant therapy with 5-FU in patients with stage II disease. MSI status can be used in the clinic as a prognostic tool to identify a subgroup of stage II patients with improved prognosis. Patients with MSI-H tumors are not suggested to have adjuvant chemotherapy while patients with MSI-L or MSS tumors can benefit from adjuvant chemotherapy. oral tegafur-uracil as an adjuvant chemotherapy in patients with Dukes' stage B2 and C2 colon cancer could be a good alternative to infusional 5-FU. Current evidences suggest adjuvant 5-FU-based therapy could improve survival outcome for patients with stage II MSI-L or MSS colon cancer, but not for patients with MSI-H colon cancer. Thus, oral tegafur-uracil is considered to have similar efficacy as 5-FU in this population.
Sponsor: National Taiwan University Hospital

Current Primary Outcome: 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.



Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: National Taiwan University Hospital

Dates:
Date Received: August 1, 2016
Date Started: September 2014
Date Completion: August 2017
Last Updated: September 5, 2016
Last Verified: September 2016