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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. 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
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
MSI-L/MSS Stage II Colon Cancer Drug: tegafur-uracil Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
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

Arm Intervention/treatment
Experimental: tegafur-uracil
tegafur-uracil treatment in patients with stage II MSI-L or MSS colon cancer
Drug: tegafur-uracil
No Intervention: Observation
Observation for one year

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

To be eligible for inclusion, each subject must fulfill all of the following criteria:

  1. pathologically confirmed adenocarcinoma of the colon with stage II disease;
  2. complete resection of primary tumor;
  3. detection of low level microsatellite instability (MSI-L) or microsatellite stable (MSS) in resected tumor sample;
  4. no prior chemotherapy or radiotherapy for colon cancer;
  5. ECOG performance status 0 to 1;
  6. age of 20 years or older;
  7. able to start the study treatment within 8 weeks after surgery;
  8. able to understand and willingness to sign a written informed consent document.

Exclusion Criteria

Subjects who fulfill any of the following criteria will be excluded from the trial:

  1. Severe postoperative complications;
  2. inadequate hematopoietic function which is defined as below:

    1. hemoglobin < 9 g/dL;
    2. absolute neutrophil count (ANC) ≤ 1,500/mm3;
    3. platelet count < 100,000/mm3;
  3. inadequate hepatic function which is defined as below:

    1. total bilirubin > 2 times upper limit of normal (ULN);
    2. hepatic transaminases (ALT and AST) > 2.5 x ULN;
  4. inadequate renal function which is defined as below:

    a.creatinine > 1.5 x ULN;

  5. significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications based on investigator's discretion;
  6. other malignancy within the past 5 years except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ;
  7. participation in another clinical trial with any investigational drug within 30 days prior to entry;
  8. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. Patients with childbearing potential should have effective contraception for both the patient and his or her partner during the study.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02887365

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Contact: Been Ren Lin, Ph.D 886-972651798

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National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Been Ren Lin    886-972651798   
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Been Ren Lin, Ph.D National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital Identifier: NCT02887365    
Other Study ID Numbers: 201407054MINC
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Keywords provided by National Taiwan University Hospital:
colon cancer
Low-Level Microsatellite-Instability
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Microsatellite Instability
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Genomic Instability
Pathologic Processes
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents