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Randomized Phase II Study of TS-1 Therapy and TS-1+PSK Therapy Against Unresectable Advanced Gastric Carcinoma and Recurrent Gastric Carcinoma


Phase 2/Phase 3
20 Years
N/A
Not Enrolling
Both
Gastric Cancer

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Trial Information

Randomized Phase II Study of TS-1 Therapy and TS-1+PSK Therapy Against Unresectable Advanced Gastric Carcinoma and Recurrent Gastric Carcinoma


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Hideaki Tahara, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Eastern Network of Cancer Immunological Therapy, Japan

Authority:

Japan: Institutional Review Board

Study ID:

ENCITJ-GC01

NCT ID:

NCT00503321

Start Date:

October 2006

Completion Date:

August 2011

Related Keywords:

  • Gastric Cancer
  • gastric cancer, TS-1, PSK
  • Carcinoma
  • Stomach Neoplasms

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