NCT00209742

Brief Summary

A randomized controlled study is conducted on patients with histological stage III colorectal cancer assigned to postoperative adjuvant therapy of uracil-tegafur plus leucovorin (UFT+LV), UFT+LV / UFT, or UFT+LV+PSK / UFT+PSK. The usefulness of the three regimens was evaluated by comparing the disease-free survival rate, overall survival rate, incidence and severity of adverse event, and quality of life.

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
340

participants targeted

Target at P25-P50 for phase_3 colorectal-cancer

Timeline
Completed

Started Apr 2005

Typical duration for phase_3 colorectal-cancer

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

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 26, 2010

Status Verified

May 1, 2010

Enrollment Period

7.7 years

First QC Date

September 12, 2005

Last Update Submit

May 24, 2010

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer,UFT,LV,Krestin,adjuvant therapy,phase III

Outcome Measures

Primary Outcomes (1)

  • 3-years disease-free survival rate (DFS)

    5-years

Secondary Outcomes (1)

  • Dose intensity (compliance), 5-year disease-free survival rate, 3- and 5-year survival rate, incidence of other adverse drug reactions, QOL

    7-years

Study Arms (3)

2

EXPERIMENTAL
Drug: UFTDrug: USEL/Leucovorin

3

EXPERIMENTAL
Drug: UFTDrug: USEL/LeucovorinDrug: Krestin

1

ACTIVE COMPARATOR
Drug: UFTDrug: USEL/Leucovorin

Interventions

UFTDRUG

P.O. everyday

Also known as: tegafur-uracil
123
USEL/LeucovorinDRUG

P.O. everyday

Also known as: Leucovorin
123
KrestinDRUG

P.O. everyday

Also known as: PSK
3

Eligibility Criteria

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

You may qualify if:

  • Patients with primary colonic carcinoma or rectal carcinoma of histological stage III, who have undergone histological curability A or B surgeries
  • Patients evaluated histologically as lymph node metastasis positive
  • Patients aged between 20 and 80 years, inclusive, at the time of acquisition of informed consent
  • Patients with performance status 0 to 2
  • Patients who have not received preoperative cancer therapy (radiotherapy, chemotherapy or immunotherapy)
  • Gastrointestinal function: Patients with no diarrhea (watery stool)
  • Patients without severe impairment of renal, hepatic and bone marrow functions
  • Patients with no serious concurrent complications (such as infection)
  • Patients who have given written informed consent to participate in this study

You may not qualify if:

  • Patients graded as curability C
  • Patients with stenosis not capable of oral intake
  • Among disease stage IIIa cases, those that are si/n(-) and ai/n(-)
  • Patients with fresh hemorrhage from the gastrointestinal tract
  • Patients with retention of body fluid necessitating treatment
  • Patients with infection, intestinal palsy or intestinal occlusion
  • Patients with the lower end of the tumor involving the peritoneal reflection
  • Patients with lower rectal cancer (Rb), involving the anal canal (P) or perianal skin (E)
  • Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer)
  • Patients who are pregnant or hope to become pregnant during the study period
  • Patients with poorly controlled diabetes or are treated by continuous use of insulin
  • Patients with a history of ischemic heart disease
  • Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study
  • Patients receiving continuous administration of steroids
  • Patients who have experienced serious drug allergy in the past
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)

Sapporo, Hokkaido, 060-8638, Japan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

TegafurLeucovorinpolysaccharide-K

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

FluorouracilUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • Masahiro Asaka, MD, PhD

    Hokkaido Gastrointestinal Cancer Study Group

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 21, 2005

Study Start

April 1, 2005

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 26, 2010

Record last verified: 2010-05

Locations

JP(1)