- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00687843
Study of TS-1 or TS-1 + PSK for Gastric Cancer Patients (TMOG-GC01)
March 20, 2012 updated by: Yoshiaki Iwasaki, M.D., Ph.D., Tokyo Metropolitan Oncology Group
Phase III Randomized Controlled Study of Postoperative Adjuvant Therapy Using TS-1 or TS-1+PSK for Stage II or III Gastric Cancer Patients
Since it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric cancer, in this study, we compare efficacy and safety of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric cancer patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
TS-1 is an oral anticancer drug approved in Japan consisting of tegafur (a pro-drug of fluorouracil, 5-FU), gimeracil and oteracil potassium.
The response rate of TS-1 in the untreated advanced gastric cancer patients was 44.6% in the late phase II study.
In 2007, efficacy of the adjuvant therapy using TS-1 in the resected gastric cancer patients was demonstrated by ACTS-GC study group conducted in Japan.
PSK is an oral anticancer drug approved in Japan consisting of protein-bound polysaccharide extracted from mycelium of Trametes (Coriolus) versicolor, a kind of mushroom.
Even though survival benefit by PSK in combination with adjuvant chemotherapy using 5-FU or tegafur in the postoperative gastric cancer patients was already demonstrated, it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric cancer.
In this study, we compare efficacy and safety of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric cancer patients.
Study Type
Interventional
Enrollment (Anticipated)
480
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan, 113-8677
- Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient who is pathologically confirmed as gastric cancer
- Patient who has received surgery with D2 or more lymph node dissection and whose final curability of surgical resection is grade A or B
- Patient whose final stage is II (except for T1), IIIA, or IIIB
- Patient without liver, peritoneal and distant metastasis, and who is negative in peritoneal cytological diagnosis
- Patient whose age at the registration is ranging between 20 and 80 years old
- Patient who has not received any preoperative therapy including radiotherapy, chemotherapy and immunotherapy
- Patient who has received surgery for gastric cancer within six weeks before the registration, and is judged to be capable of oral administration
Patient who has no serious concurrent complications, and satisfies the following criteria
- White blood cell count: > LLN or > 4,000 /mm3
- Platelet count: > 100,000 /mm3
- Serum total bilirubin: < 1.5 mg/dL
- Serum AST (GOT), ALT (GPT): < 2.5 * ULN
- Serum creatinine: < ULN
- Patient who has received an explanation of this study by assent documents, and has given written informed consent to participate in this study
Exclusion Criteria:
- Patient with metachronous or synchronous multicancer
- Patient who contraindicates to TS-1
- Patient who requires continuous use of flucytosine, phenytoin or warfarin potassium
- Patient who has experienced serious drug allergy over grade 3 in the past
- Patient with serious complications including paralysis of intestine, ileus, interstitial pneumonitis, fibroid lung, uncontrollable diabetes mellitus, heart insufficiency, renal insufficiency or hepatic insufficiency
- Patient with diarrhea (watery stool)
- Patient who is pregnant or in lactation, or wish to become pregnant during this study
- Male patient who intends to make someone pregnant during this study
- Patient with HIV positive
- Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
The TS-1 group
|
80 mg/m2, PO from day 1 to day 28 of each 42 day cycle.
Number of Cycles: 8
Other Names:
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Experimental: 2
The TS-1+PSK Group
|
80 mg/m2, PO from day 1 to day 28 of each 42 day cycle.
Number of Cycles: 8
Other Names:
3 g, PO from day 1 to day 336
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relapse-free survival
Time Frame: Five years after surgery
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Five years after surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival, quality of life, drug compliance, adverse events, serial changes of tumor markers
Time Frame: Five years after surgery
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Five years after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Masatsugu Kitamura, MD
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252. Erratum In: N Engl J Med. 2008 May 1;358(18):1977.
- Nakazato H, Koike A, Saji S, Ogawa N, Sakamoto J. Efficacy of immunochemotherapy as adjuvant treatment after curative resection of gastric cancer. Study Group of Immunochemotherapy with PSK for Gastric Cancer. Lancet. 1994 May 7;343(8906):1122-6. doi: 10.1016/s0140-6736(94)90233-x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Anticipated)
March 1, 2016
Study Completion (Anticipated)
March 1, 2016
Study Registration Dates
First Submitted
May 28, 2008
First Submitted That Met QC Criteria
May 30, 2008
First Posted (Estimate)
June 2, 2008
Study Record Updates
Last Update Posted (Estimate)
March 22, 2012
Last Update Submitted That Met QC Criteria
March 20, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Protective Agents
- Adjuvants, Immunologic
- Antibiotics, Antineoplastic
- Interferon Inducers
- Radiation-Protective Agents
- Tegafur
- polysaccharide-K
Other Study ID Numbers
- TMOG-GC01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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