Study of TS-1 or TS-1 + PSK for Gastric Cancer Patients

NCT00687843 | Unknown Phase 3 DMC

• 1 other identifier: TMOG-GC01
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer

Keywords

Gastric Cancer; TS-1; PSK; Relapse-free survival

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival

  Five years after surgery

Secondary Outcomes (1)

• Overall survival, quality of life, drug compliance, adverse events, serial changes of tumor markers

  Five years after surgery

Study Arms (2)

1

ACTIVE COMPARATOR

The TS-1 group

Drug: Tegafur-gimeracil-oteracil potassium (TS-1)

2

EXPERIMENTAL

The TS-1+PSK Group

Drug: Tegafur-gimeracil-oteracil potassium (TS-1); Drug: Krestin (PSK)

Interventions

Tegafur-gimeracil-oteracil potassium (TS-1) DRUG

80 mg/m2, PO from day 1 to day 28 of each 42 day cycle. Number of Cycles: 8

Also known as: TS-1

1; 2

Krestin (PSK) DRUG

3 g, PO from day 1 to day 336

Also known as: PSK

2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tokyo Metropolitan Oncology Group: lead

Study Sites (1)

Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital

Tokyo, Tokyo, 113-8677, Japan

Location

Related Publications (2)

• 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.

  PMID: 17978289 BACKGROUND

• 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.

  PMID: 7910230 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

titanium silicide; polysaccharide-K

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Masatsugu Kitamura, MD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Surgery, Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital.

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: June 2, 2008
• Study Start: June 1, 2008
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 22, 2012

Record last verified: 2012-03

Locations

JP (1)