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Maintenance Tegafur-uracil Versus Observation Following Adjuvant Oxaliplatin-based Regimen in Patients With Stage III Colon Cancer After Radical Resection

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ClinicalTrials.gov Identifier: NCT02836977
Recruitment Status : Active, not recruiting
First Posted : July 19, 2016
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Description
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Brief Summary:

Primary Objective:

To compare 3-year disease free survival (DFS) of tegafur-uracil following adjuvant oxaliplatin-based regimen to observation following adjuvant oxaliplatin-based regimen in patients with stage III colon cancer after radical resection.

Secondary Objectives:

  • To assess 5-year overall survival (OS) in each arm
  • To assess the safety profiles

Condition or disease Intervention/treatment Phase
Stage III Colon Cancer Drug: tegafur-uracil Not Applicable

Detailed Description:

Objectives:

  1. Primary Objective:

    To compare 3-year disease free survival (DFS) of tegafur-uracil following adjuvant oxaliplatin-based regimen to observation following adjuvant oxaliplatin-based regimen in patients with stage III colon cancer after radical resection.

  2. Secondary Objectives:

    • To assess 5-year overall survival (OS) in each arm
    • To assess the safety profiles

Patient Selection and Enrollment:

Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 2:1, to reach approximately 546 patients in total.

Plan of the Study:

  1. Study Design This is an open-label, randomized, comparative, double arm, multicenter study to assess disease free survival, overall survival, safety profiles with tegafur-uracil following adjuvant oxaliplatin-based regimen as maintenance for one-year in patients with stage III colon cancer after radical resection in Taiwan.
  2. Subject Number Eligible patients will be randomized in 2 arms in the ratio of 2:1, to reach approximately 546 patients in total.
  3. Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB) Expected recruitment rate: 23 subjects/month Duration of recruitment: at least 2 years. Duration of the study: at least 5 years.
  4. Visit Schedule The schedule of assessments (please refer section 8.4 for the details) indicates the number and timing of the planned visits, which must be maintained as accurately as possible. The visit schedule must be maintained as accurate as possible.
  5. Duration of Treatment Treatment should be administered up to maximum one year, disease progression, intolerable toxicity, or consent withdrawal during any time of the study, the patient will be withdraw.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : February 29, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: maintenance therapy
Patients will receive oral tegafur-uracil 400mg/day (100mg/Cap., 2 capsules each time, twice a day), combined with oral folinic acid 30mg/day (15mg/Tab., 1 tablet each time, twice a day), and continue for one year.
 Drug: tegafur-uracil
Eligible patients will receive tegafur-uracil orally at a dose of 400mg/day (100mg/Cap., 2 capsules each time, twice a day) and folinic acid 30mg/day (15mg/Tab., 1 tablet each time, twice a day) for one year.
Other Name: UFUR
Active Comparator: observation arm
Patients will be observed following adjuvant oxaliplatin-based regimen.
 Drug: tegafur-uracil
Eligible patients will receive tegafur-uracil orally at a dose of 400mg/day (100mg/Cap., 2 capsules each time, twice a day) and folinic acid 30mg/day (15mg/Tab., 1 tablet each time, twice a day) for one year.
Other Name: UFUR


Outcome Measures
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Primary Outcome Measures :
  1. Disease free survival [ Time Frame: three to six months ]

Eligibility Criteria
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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
Criteria

Inclusion Criteria:

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

  1. pathologically confirmed colon carcinoma;
  2. stage III disease (T1-4, N1-2, M0 as defined by AJCC 7th Edi.);
  3. completion of adjuvant oxaliplatin-based regimen without evidence of any recurrent disease;
  4. entry of the trial within 3 weeks after adjuvant oxaliplatin-based regimen;
  5. performance status of ECOG 0, 1, 2;
  6. age between 20 and 80 years old;
  7. written informed consent to participate in the trial.

Exclusion Criteria:

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

  1. previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years;

  2. inadequate hematopoietic function defined as below:

    1. hemoglobin < 9 g/dL;
    2. absolute neutrophil count (ANC) < 1,500/mm3;
    3. platelet count < 100,000/mm3;

  3. inadequate organ functions defined as below:

    1. total bilirubin > 2 times upper limit of normal (ULN);
    2. hepatic transaminases (ALT and AST) > 2.5 x ULN;
    3. creatinine > 1.5 x ULN;
  4. other significant medical conditions that are contraindicated to tegafur-uracil or render patient at high risk from treatment complications based on investigator's discretion;
  5. presence of other serious concomitant illness;
  6. participation in another clinical trial with any investigational drug within 30 days prior to entry;
  7. pregnant or lactating women or women of childbearing potential.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02836977


Locations
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Taiwan
Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT02836977    
Other Study ID Numbers: KMUHIRB-F(I)-20160016
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
tegafur-uracil
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Tegafur
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents