Randomized Phase III Adjuvant Study for Stage III Colorectal Cancer - Full Text View

Sponsors and Collaborators:	Hokkaido Gastrointestinal Cancer Study Group Hokkaido University Hospital
Information provided by:	Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier:	NCT00209742

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Leucovorin Citrovorum factor Krestin Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

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:	October 2010
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental	Drug: UFT P.O. everyday Drug: USEL/Leucovorin P.O. everyday
3: Experimental	Drug: UFT P.O. everyday Drug: USEL/Leucovorin P.O. everyday Drug: Krestin P.O. everyday
1: Active Comparator	Drug: UFT P.O. everyday Drug: USEL/Leucovorin P.O. everyday

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:

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

Exclusion Criteria:

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
Others, patients judged by the investigator or subinvestigator to be inappropriate as subject

Contacts and Locations

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

Locations

Japan, Hokkaido
・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)	Recruiting
Sapporo, Hokkaido, Japan, 060-8638
Contact: Yoshito Komatsu, MD,Phd 81-11-716-1161 ykomatsu@med.hokudai.ac.jp
Contact: Satoshi Yuki 81-11-716-1161 satoshi-yuuki175@joy.ocn.ne.jp
Principal Investigator: Yoshito Komatsu, MD,Phd

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:	Hokkaido Gastrointestina Cancer Study Group ( Yoshito Komatsu / A vice-director, )
Study ID Numbers:	HGCSG-CAD
Study First Received:	September 12, 2005
Last Updated:	February 16, 2009
ClinicalTrials.gov Identifier:	NCT00209742 History of Changes
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

Study placed in the following topic categories:

Anti-Infective Agents
Radiation-Protective Agents
Vitamin B Complex
Digestive System Neoplasms
Immunologic Factors
Gastrointestinal Diseases
Tegafur
Interferons
Colonic Diseases
Adjuvants, Immunologic
Leucovorin
Trace Elements

Folinic Acid
Intestinal Diseases
Antiviral Agents
Rectal Diseases
Intestinal Neoplasms
Anti-Bacterial Agents
Digestive System Diseases
Vitamins
Gastrointestinal Neoplasms
Micronutrients
PS-K
Colorectal Neoplasms

Additional relevant MeSH terms:

Interferon Inducers
Anti-Infective Agents
Radiation-Protective Agents
Immunologic Factors
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Physiological Effects of Drugs
Leucovorin
Antibiotics, Antineoplastic
Rectal Diseases
Neoplasms by Site
Vitamins
Therapeutic Uses
Micronutrients

Digestive System Neoplasms
Vitamin B Complex
Growth Substances
Adjuvants, Immunologic
Intestinal Diseases
Protective Agents
Antiviral Agents
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
PS-K
Colorectal Neoplasms

ClinicalTrials.gov processed this record on August 30, 2009