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

21:40 EDT 3rd July 2015 | BioPortfolio

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.

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.

Study Design

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

Conditions

Gastric Cancer

Intervention

Tegafur-gimeracil-oteracil potassium (TS-1), Krestin (PSK)

Location

Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Tokyo
Japan
113-8677

Status

Recruiting

Source

Tokyo Metropolitan Oncology Group

Results (where available)

View Results

Links

Clinical Trials [586 Associated Clinical Trials listed on BioPortfolio]

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

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 ...

Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK

A randomized controlled study is conducted on patients with resected gastric cancer assigned to postoperative adjuvant therapy of TS-1 alone or PSK combined with TS-1, with the objective t...

Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial

The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and esophagoga...

A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer

To compare the efficacy of tegafur/uracil (UFT) plus folinate calcium (leucovorin: LV) administered orally and UFT plus Krestin (PSK) administered orally enrolling patients with pTNM stage...

Pharmacokinetic and Pharmacodynamic Study of S-1 in Patients With Digestive Organ Cancer

S-1 is a novel oral fluorouracil antitumor drug that consists of tegafur which is a prodrug of 5-fluorouracil (5-FU); 5-chloro-2,4-dihydropyridine (CDHP), which inhibits dihydropyrimidine ...

PubMed Articles [14509 Associated PubMed Articles listed on BioPortfolio]

Effectiveness and Safety of Tegafur-Gimeracil-Oteracil Potassium(TS-1)for Metastatic Breast Cancer: A Single-Center Retrospective Study.

Tegafur-gimeracil-oteracil potassium(TS-1)is a drug that is used mainly as a third-line treatment or beyond for metastatic breast cancer(MBC). However, there is still insufficient evidence on its clin...

A case of jejunal ectopic pancreatic cancer: the diagnostic usefulness of MRI.

A 70-year-old man was referred to our hospital because of elevated CA19-9. Magnetic resonance imaging revealed a jejunal tumor having duct and retention cyst-like structures, which suggested ectopic p...

Effect of TRAIL in combination with DDP on the expression of MDR1 gene in gastric cancer cells.

Gastric cancer is one of the most common malignant tumor, and gastric cancer is the second most common cause of cancer mortality worldwide. Although chemotherapy is one of the most important treatment...

Gastric cancer: past progress and present challenges.

Familial gastric cancer: genetic susceptibility, pathology, and implications for management.

Familial gastric cancer comprises at least three major syndromes: hereditary diffuse gastric cancer, gastric adenocarcinoma and proximal polyposis of the stomach, and familial intestinal gastric cance...

Medical and Biotech [MESH] Definitions

That portion of the stomach remaining after gastric surgery, usually gastrectomy or gastroenterostomy for cancer of the stomach or peptic ulcer. It is a common site of cancer referred to as stump cancer or carcinoma of the gastric stump.

A proto-oncogene protein and member of the Wnt family of proteins. It is frequently up-regulated in human GASTRIC CANCER and is a tumor marker (TUMOR MARKERS, BIOLOGICAL) of gastric and COLORECTAL CANCER.

A condition due to decreased dietary intake of potassium, as in starvation or failure to administer in intravenous solutions, or to gastrointestinal loss in diarrhea, chronic laxative abuse, vomiting, gastric suction, or bowel diversion. Severe potassium deficiency may produce muscular weakness and lead to paralysis and respiratory failure. Muscular malfunction may result in hypoventilation, paralytic ileus, hypotension, muscle twitches, tetany, and rhabomyolysis. Nephropathy from potassium deficit impairs the concentrating mechanism, producing polyuria and decreased maximal urinary concentrating ability with secondary polydipsia. (Merck Manual, 16th ed)

Abnormal distention of the STOMACH due to accumulation of gastric contents that may reach 10 to 15 liters. Gastric dilatation may be the result of GASTRIC OUTLET OBSTRUCTION; ILEUS; GASTROPARESIS; or denervation.

Stable potassium atoms that have the same atomic number as the element potassium, but differ in atomic weight. K-41 is a stable potassium isotope.

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