Randomized Phase III Adjuvant Study for Stage III Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Hokkaido Gastrointestinal Cancer Study Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Hokkaido University Hospital
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00209742
First received: September 12, 2005
Last updated: May 24, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: UFT
Drug: USEL/Leucovorin
Drug: Krestin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase III Clinical Study Comparing Postoperative UFT+LV, UFT+LV/UFT and UFT+LV+PSK/UFT+PSK Therapies for Stage III Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Hokkaido Gastrointestinal Cancer Study Group:

Primary Outcome Measures:
  • 3-years disease-free survival rate (DFS) [ Time Frame: 5-years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dose intensity (compliance), 5-year disease-free survival rate, 3- and 5-year survival rate, incidence of other adverse drug reactions, QOL [ Time Frame: 7-years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 340
Study Start Date: April 2005
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 Drug: UFT
P.O. everyday
Other Name: tegafur-uracil
Drug: USEL/Leucovorin
P.O. everyday
Other Name: Leucovorin
Experimental: 3 Drug: UFT
P.O. everyday
Other Name: tegafur-uracil
Drug: USEL/Leucovorin
P.O. everyday
Other Name: Leucovorin
Drug: Krestin
P.O. everyday
Other Name: PSK
Active Comparator: 1 Drug: UFT
P.O. everyday
Other Name: tegafur-uracil
Drug: USEL/Leucovorin
P.O. everyday
Other Name: Leucovorin

Detailed Description:

A multicenter randomized open-label controlled study is conducted on patients with histological stage III and curability A or B colorectal cancer [according to General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus, 6th edition (Japanese Classification of Colorectal Cancer, English edition), also according to pTNM classification to facilitate overseas publication] given postoperative oral therapy of tegafur-uracil plus leucovorin (UFT+LV) (5 courses), UFT+LV (5 courses) / UFT (1 year), or UFT+LV+PSK (5 courses) / UFT+PSK (1 year). The usefulness of the three regimens as postoperative adjuvant therapy was evaluated by comparing the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event, and quality of life (QOL).

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients graded as curability C
  2. Patients with stenosis not capable of oral intake
  3. Among disease stage IIIa cases, those that are si/n(-) and ai/n(-)
  4. Patients with fresh hemorrhage from the gastrointestinal tract
  5. Patients with retention of body fluid necessitating treatment
  6. Patients with infection, intestinal palsy or intestinal occlusion
  7. Patients with the lower end of the tumor involving the peritoneal reflection
  8. Patients with lower rectal cancer (Rb), involving the anal canal (P) or perianal skin (E)
  9. 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)
  10. Patients who are pregnant or hope to become pregnant during the study period
  11. Patients with poorly controlled diabetes or are treated by continuous use of insulin
  12. Patients with a history of ischemic heart disease
  13. Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study
  14. Patients receiving continuous administration of steroids
  15. Patients who have experienced serious drug allergy in the past
  16. Others, patients judged by the investigator or subinvestigator to be inappropriate as subject
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209742

Locations
Japan
・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)
Sapporo, Hokkaido, Japan, 060-8638
Sponsors and Collaborators
Hokkaido Gastrointestinal Cancer Study Group
Hokkaido University Hospital
Investigators
Study Chair: Masahiro Asaka, MD, PhD Hokkaido Gastrointestinal Cancer Study Group
  More Information

No publications provided

Responsible Party: Yoshito Komatsu / A vice-director,, Hokkaido Gastrointestina Cancer Study Group
ClinicalTrials.gov Identifier: NCT00209742     History of Changes
Other Study ID Numbers: HGCSG-CAD
Study First Received: September 12, 2005
Last Updated: May 24, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Hokkaido Gastrointestinal Cancer Study Group:
Colorectal Cancer,UFT,LV,Krestin,adjuvant therapy,phase III

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Levoleucovorin
Krestin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Interferon Inducers

ClinicalTrials.gov processed this record on July 23, 2014