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

Phase 4

• Conditions: MSI-L/MSS; Stage II Colon Cancer
• Interventions: Drug: tegafur-uracil

• Registration Number: NCT02887365
• Lead Sponsor: National Taiwan University Hospital

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 Description

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-29
• Status Verified: 2016-09
• Study First Posted: 2016-09-02
• Last Update Submitted: 2016-09-05
• Last Update Posted: 2016-09-07
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tegafur-uracil	tegafur-uracil	tegafur-uracil treatment in patients with stage II MSI-L or MSS colon cancer

Primary Outcome Measures

Name	Time	Method
3-year disease-free survival Safety profile of tegafur-uracil	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.

Secondary Outcome Measures

Name	Time	Method
5-year overall survival	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan