NCT02836977

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

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
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

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

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

February 8, 2017

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

July 10, 2016

Last Update Submit

February 6, 2017

Conditions

Stage III Colon Cancer

Keywords

tegafur-uracil

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    three to six months

Study Arms (2)

maintenance therapy

EXPERIMENTAL

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

observation arm

ACTIVE COMPARATOR

Patients will be observed following adjuvant oxaliplatin-based regimen.

Drug: tegafur-uracil

Interventions

tegafur-uracilDRUG

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.

Also known as: UFUR
maintenance therapyobservation arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Patients who fulfill any of the following criteria will be excluded from the trial:
  • 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;
  • inadequate hematopoietic function defined as below:
  • hemoglobin \< 9 g/dL;
  • absolute neutrophil count (ANC) \< 1,500/mm3;
  • platelet count \< 100,000/mm3;
  • inadequate organ functions defined as below:
  • total bilirubin \> 2 times upper limit of normal (ULN);
  • hepatic transaminases (ALT and AST) \> 2.5 x ULN;
  • creatinine \> 1.5 x ULN;
  • other significant medical conditions that are contraindicated to tegafur-uracil or render patient at high risk from treatment complications based on investigator's discretion;
  • presence of other serious concomitant illness;
  • participation in another clinical trial with any investigational drug within 30 days prior to entry;
  • pregnant or lactating women or women of childbearing potential.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Kaohsiung City, 807, Taiwan

Location

Related Publications (1)

  • Yeh YS, Tsai HL, Huang CW, Wei PL, Sung YC, Tang HC, Wang JY. Maintenance tegafur-uracil versus observation following an adjuvant oxaliplatin-based regimen in patients with stage III colon cancer after radical resection: study protocol for a randomized controlled trial. Trials. 2017 Apr 26;18(1):191. doi: 10.1186/s13063-017-1904-9.

    PMID: 28441966DERIVED

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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2016

First Posted

July 19, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

February 29, 2024

Last Updated

February 8, 2017

Record last verified: 2016-06

Locations

TW(1)