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Sponsors and Collaborators: |
Hokkaido Gastrointestinal Cancer Study Group Hokkaido University Hospital |
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Information provided by: | Hokkaido Gastrointestinal Cancer Study Group |
ClinicalTrials.gov Identifier: | NCT00209742 |
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 |
Estimated Enrollment: | 340 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | October 2008 |
Arms | Assigned Interventions |
---|---|
2: Experimental |
Drug: UFT
P.O. everyday
Drug: USEL/Leucovorin
P.O. everyday
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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
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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).
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Chair: | Masahiro Asaka, MD, PhD | Hokkaido Gastrointestinal Cancer Study Group |
Study ID Numbers: | HGCSG-CAD |
Study First Received: | September 12, 2005 |
Last Updated: | October 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00209742 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Colorectal Cancer,UFT,LV,Krestin,adjuvant therapy,phase III |
Digestive System Neoplasms Gastrointestinal Diseases Tegafur Colonic Diseases Interferons Leucovorin Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Digestive System Diseases Gastrointestinal Neoplasms PS-K Colorectal Neoplasms |
Interferon Inducers Anti-Infective Agents Radiation-Protective Agents Vitamin B Complex Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Adjuvants, Immunologic |
Antibiotics, Antineoplastic Protective Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Vitamins Therapeutic Uses Micronutrients |