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

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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
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE August 1, 2016
First Posted Date  ICMJE September 2, 2016
Last Update Posted Date September 7, 2016
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2016)
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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02887365 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2016)
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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Study of Tegafur-Uracil as Maintenance Chemotherapy in Patients With Stage II of Colon Cancer
Official Title  ICMJE 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE
  • MSI-L/MSS
  • Stage II Colon Cancer
Intervention  ICMJE Drug: tegafur-uracil
Study Arms  ICMJE
  • Experimental: tegafur-uracil
    tegafur-uracil treatment in patients with stage II MSI-L or MSS colon cancer
    Intervention: Drug: tegafur-uracil
  • No Intervention: Observation
    Observation for one year
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 29, 2016)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02887365
Other Study ID Numbers  ICMJE 201407054MINC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Been Ren Lin, Ph.D National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP