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Phase II Study of TS-1 Therapy and TS-1+PSK Therapy Against Advanced Gastric Carcinoma (eNCIT-Japan)

Primary Purpose

Gastric Cancer

Status
Terminated
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Tegafur/gimeracil/oteracil potassium (S-1), Krestin (PSK)
Tegafur/gimeracil/oteracil potassium (S-1)
Sponsored by
Eastern Network of Cancer Immunological Therapy, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, TS-1, PSK

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with unresectable advanced gastric carcinoma and recurrent gastric carcinoma.
  • Patients who are 20 years old or older at the time of obtaining consent.
  • Patients who have not received prior treatment, including radiotherapy, chemotherapy and immunotherapy, before the start of treatment (however, patients are excluded when six months or more have passed since they received postoperative adjuvant chemotherapy.)
  • Patients who do not develop metachronous or simultaneous multi cancer.
  • Patients who do not show severe impairments in renal function, liver function and bone marrow function and who maintain the major organ functions which meet all requirements as described below (laboratory values are values measured before the start of protocol treatment and should be updated ones which are measured within two weeks before protocol treatment is started.) WBC counts: >= 3,000 /mm3 and < 12,000 /mm3 Neutrophil counts (ANC): >= 1,500 /mm3 Platelet counts: >= 100,000 /mm3 Amount of hemoglobin: >= 8.0 g/dL Serum GOT and GPT: Less than 100 IU/L Serum total bilirubin: Less than 1.5 mg/dL Serum creatinine: Less than 1.5 mg/dL
  • Patients whose performance status scores are 0 to 2.
  • Patients who are judged that they can endure this treatment in a comprehensive manner and who have provided written informed consent to participate in this research.
  • Presence or absence of measurable lesion does not matter, but if there are measurable lesions in patients, the lesions should be confirmed within 28 days before the enrollment.

Exclusion Criteria:

  • Patients with fresh blood in the digestive tract.
  • Patients with body fluids which require treatment.
  • Patients with infectious disease, intestinal paresis and ileus.
  • Patients with diarrhea (watery stool).
  • Female patients who are pregnant or want to become pregnant during this study or male patients who intend to make someone pregnant during this study.
  • Diabetic patients who are being treated with insulin or are poorly controlled.
  • Patients with ischemic heart disease which require treatment
  • Patients who are complicated with psychosis and judged that it is difficult for them to participate in this study.
  • Patients who continue to receive steroids.
  • Patients who have experienced serious drug allergy in the past.
  • Patients who are taking health foods including agaricus which are considered to have immunostimulating effects.
  • Patients judged to be inappropriate for this study by investigators and sub-investigators.

Sites / Locations

  • Shizuoka Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm B

Arm A

Arm Description

S-1 plus PSK group

S-1 alone

Outcomes

Primary Outcome Measures

progression-free survival

Secondary Outcome Measures

Anticancer effect, time to treatment failure (TTF), QOL (FACT-BRM), compliance, adverse drug reactions and immunological factors

Full Information

First Posted
July 16, 2007
Last Updated
January 22, 2009
Sponsor
Eastern Network of Cancer Immunological Therapy, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00503321
Brief Title
Phase II Study of TS-1 Therapy and TS-1+PSK Therapy Against Advanced Gastric Carcinoma
Acronym
eNCIT-Japan
Official Title
Randomized Phase II Study of TS-1 Therapy and TS-1+PSK Therapy Against Unresectable Advanced Gastric Carcinoma and Recurrent Gastric Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Terminated
Why Stopped
Patients' enrollment was not sufficient.
Study Start Date
October 2006 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Network of Cancer Immunological Therapy, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized controlled study is conducted on unresectable advanced gastric carcinoma and recurrent gastric carcinoma to compare TS-1 therapy with TS-1 + PSK therapy. The primary endpoint of this study is progression-free survival (PFS), with secondary endpoints of anticancer effect, time to treatment failure (TTF), QOL (FACT-BRM), compliance, adverse drug reactions and immunological factors.
Detailed Description
Tegafur / gimeracil / oteracil potassium (TS-1) is widely used as a first-line drug for unresectable advanced gastric carcinoma and recurrent gastric carcinoma in Japan and the response rate of TS-1 against gastric carcinoma was reported to be excellent at 46.5% in a phase II study. However, since adverse drug reactions tend to occur in patients treated with standard regimen of TS-1, drug reduction or discontinuation is often required, which is one drawback of this drug. On the other hand, although Krestin (PSK) has been reported to show survival effects in postoperative immunochemotherapy against gastric carcinoma, the efficacy of PSK has not been established in patients with unresectable advanced gastric carcinoma and recurrent gastric carcinoma. Since the main effect of PSK was to recover physiological functions, including immune function of the host, it was expected that PSK would improve the compliance of TS-1 by alleviating adverse drug reactions of TS-1 therapy and the concomitant use of TS-1 with PSK would result in the improvement of treatment results. Therefore, we decided to conduct a randomized phase II study on patients with unresectable advanced gastric carcinoma and recurrent gastric carcinoma to compare TS-1 therapy with TS-1+PSK therapy.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm B
Arm Type
Experimental
Arm Description
S-1 plus PSK group
Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
S-1 alone
Intervention Type
Drug
Intervention Name(s)
Tegafur/gimeracil/oteracil potassium (S-1), Krestin (PSK)
Other Intervention Name(s)
S-1 plus PSK
Intervention Description
S-1 80mg/m2 4weeks on 2 weeks off, PSK 3g/day
Intervention Type
Drug
Intervention Name(s)
Tegafur/gimeracil/oteracil potassium (S-1)
Other Intervention Name(s)
S-1 alone
Intervention Description
S-1 80mg/m2, 4weeks on followed by 2 weks off
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Anticancer effect, time to treatment failure (TTF), QOL (FACT-BRM), compliance, adverse drug reactions and immunological factors
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with unresectable advanced gastric carcinoma and recurrent gastric carcinoma. Patients who are 20 years old or older at the time of obtaining consent. Patients who have not received prior treatment, including radiotherapy, chemotherapy and immunotherapy, before the start of treatment (however, patients are excluded when six months or more have passed since they received postoperative adjuvant chemotherapy.) Patients who do not develop metachronous or simultaneous multi cancer. Patients who do not show severe impairments in renal function, liver function and bone marrow function and who maintain the major organ functions which meet all requirements as described below (laboratory values are values measured before the start of protocol treatment and should be updated ones which are measured within two weeks before protocol treatment is started.) WBC counts: >= 3,000 /mm3 and < 12,000 /mm3 Neutrophil counts (ANC): >= 1,500 /mm3 Platelet counts: >= 100,000 /mm3 Amount of hemoglobin: >= 8.0 g/dL Serum GOT and GPT: Less than 100 IU/L Serum total bilirubin: Less than 1.5 mg/dL Serum creatinine: Less than 1.5 mg/dL Patients whose performance status scores are 0 to 2. Patients who are judged that they can endure this treatment in a comprehensive manner and who have provided written informed consent to participate in this research. Presence or absence of measurable lesion does not matter, but if there are measurable lesions in patients, the lesions should be confirmed within 28 days before the enrollment. Exclusion Criteria: Patients with fresh blood in the digestive tract. Patients with body fluids which require treatment. Patients with infectious disease, intestinal paresis and ileus. Patients with diarrhea (watery stool). Female patients who are pregnant or want to become pregnant during this study or male patients who intend to make someone pregnant during this study. Diabetic patients who are being treated with insulin or are poorly controlled. Patients with ischemic heart disease which require treatment Patients who are complicated with psychosis and judged that it is difficult for them to participate in this study. Patients who continue to receive steroids. Patients who have experienced serious drug allergy in the past. Patients who are taking health foods including agaricus which are considered to have immunostimulating effects. Patients judged to be inappropriate for this study by investigators and sub-investigators.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hideaki Tahara, MD
Organizational Affiliation
Eastern Network of Cancer Immunological Therapy, Japan
Official's Role
Study Chair
Facility Information:
Facility Name
Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan

12. IPD Sharing Statement

Citations:
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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Phase II Study of TS-1 Therapy and TS-1+PSK Therapy Against Advanced Gastric Carcinoma

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