NCT02887365

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

2.9 years

First QC Date

August 1, 2016

Last Update Submit

September 5, 2016

Conditions

MSI-L/MSSStage II Colon Cancer

Keywords

colon cancerMSI-LMSSTegafur-UracilLow-Level Microsatellite-Instability

Outcome Measures

Primary Outcomes (1)

  • 3-year disease-free survival Safety profile of tegafur-uracil

    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.

    3 years

Secondary Outcomes (1)

  • 5-year overall survival

    3 years

Study Arms (2)

tegafur-uracil

EXPERIMENTAL

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

Drug: tegafur-uracil

Observation

NO INTERVENTION

Observation for one year

Interventions

tegafur-uracilDRUG
tegafur-uracil

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Subjects who fulfill any of the following criteria will be excluded from the trial:
  • Severe postoperative complications;
  • inadequate hematopoietic function which is defined as below:
  • hemoglobin \< 9 g/dL;
  • absolute neutrophil count (ANC) ≤ 1,500/mm3;
  • platelet count \< 100,000/mm3;
  • inadequate hepatic function which is defined as below:
  • total bilirubin \> 2 times upper limit of normal (ULN);
  • hepatic transaminases (ALT and AST) \> 2.5 x ULN;
  • inadequate renal function which is defined as below:
  • a.creatinine \> 1.5 x ULN;
  • significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications based on investigator's discretion;
  • other malignancy within the past 5 years except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ;
  • participation in another clinical trial with any investigational drug within 30 days prior to entry;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Tegafur

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

FluorouracilUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Been Ren Lin, Ph.D

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Been Ren Lin, Ph.D

CONTACT

886-972651798dtsurg92@yahoo.com.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2016

First Posted

September 2, 2016

Study Start

September 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations

TW(1)