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

This study has been terminated.
(Patients' enrollment was not sufficient.)
Sponsor:
Information provided by:
Eastern Network of Cancer Immunological Therapy, Japan
ClinicalTrials.gov Identifier:
NCT00503321
First received: July 16, 2007
Last updated: January 22, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: Tegafur/gimeracil/oteracil potassium (S-1), Krestin (PSK)
Drug: Tegafur/gimeracil/oteracil potassium (S-1)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of TS-1 Therapy and TS-1+PSK Therapy Against Unresectable Advanced Gastric Carcinoma and Recurrent Gastric Carcinoma

Resource links provided by NLM:


Further study details as provided by Eastern Network of Cancer Immunological Therapy, Japan:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anticancer effect, time to treatment failure (TTF), QOL (FACT-BRM), compliance, adverse drug reactions and immunological factors [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: October 2006
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm B
S-1 plus PSK group
Drug: Tegafur/gimeracil/oteracil potassium (S-1), Krestin (PSK)
S-1 80mg/m2 4weeks on 2 weeks off, PSK 3g/day
Other Name: S-1 plus PSK
Active Comparator: Arm A
S-1 alone
Drug: Tegafur/gimeracil/oteracil potassium (S-1)
S-1 80mg/m2, 4weeks on followed by 2 weks off
Other Name: S-1 alone

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503321

Locations
Japan
Shizuoka Cancer Center
Shizuoka, Japan, 411-8777
Sponsors and Collaborators
Eastern Network of Cancer Immunological Therapy, Japan
Investigators
Study Chair: Hideaki Tahara, MD Eastern Network of Cancer Immunological Therapy, Japan
  More Information

Additional Information:
Publications:
Responsible Party: Masanori Terashima, Shizuoka Cancer Center
ClinicalTrials.gov Identifier: NCT00503321     History of Changes
Other Study ID Numbers: ENCITJ-GC01
Study First Received: July 16, 2007
Last Updated: January 22, 2009
Health Authority: Japan: Institutional Review Board
Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eastern Network of Cancer Immunological Therapy, Japan:
gastric cancer, TS-1, PSK

Additional relevant MeSH terms:
Carcinoma
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Tegafur
Krestin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Interferon Inducers
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 23, 2014