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Study of TS-1 or TS-1 + PSK for Gastric Cancer Patients (TMOG-GC01)

Primary Purpose

Gastric Cancer

Status

Unknown status

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Tegafur-gimeracil-oteracil potassium (TS-1)

Krestin (PSK)

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, TS-1, PSK, Relapse-free survival

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

The TS-1 group

The TS-1+PSK Group

Outcomes

Primary Outcome Measures

Relapse-free survival

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00687843

First Posted

May 28, 2008

Last Updated

March 20, 2012

Sponsor

Tokyo Metropolitan Oncology Group

1. Study Identification

Unique Protocol Identification Number

NCT00687843

Brief Title

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

Acronym

TMOG-GC01

Official Title

Phase III Randomized Controlled Study of Postoperative Adjuvant Therapy Using TS-1 or TS-1+PSK for Stage II or III Gastric Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

June 2008 (undefined)

Primary Completion Date

March 2016 (Anticipated)

Study Completion Date

March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tokyo Metropolitan Oncology Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

The TS-1 group

Arm Title

Arm Type

Experimental

Arm Description

The TS-1+PSK Group

Intervention Type

Drug

Intervention Name(s)

Tegafur-gimeracil-oteracil potassium (TS-1)

Other Intervention Name(s)

TS-1

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Krestin (PSK)

Other Intervention Name(s)

PSK

Intervention Description

3 g, PO from day 1 to day 336

Primary Outcome Measure Information:

Title

Relapse-free survival

Time Frame

Five years after surgery

Secondary Outcome Measure Information:

Title

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

Time Frame

Five years after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Masatsugu Kitamura, MD

Official's Role

Study Chair

Facility Information:

Facility Name

Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital

City

Tokyo

ZIP/Postal Code

113-8677

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

17978289

Citation

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.

Results Reference

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PubMed Identifier

7910230

Citation

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.

Results Reference

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

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