Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Bone Density Conservation Agents

Anti-Infective Agents

Hematinics

Vitamins

Leucovorin

Levoleucovorin

Tegafur

Calcium

Calcium, Dietary

polysaccharide-K

Hormones

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Antimetabolites

Adjuvants, Immunologic

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antiviral Agents

Interferons

Radiation-Protective Agents

Folinic Acid

Folate

Vitamin B9

UFT+LV Group: The group treated with UFT and LV

UFT+PSK Group: The group treated with of UFT and PSK

From within 9 weeks after surgery, 300 mg/m2, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5

Tegafur-uracil (UFT)

From within 9 weeks after surgery, 75 mg, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5

Calcium folinate (LV)

From within 9 weeks after surgery to 12 months after surgery, 3 g/day, PO every day

Krestin (PSK)

Morito Monden, MD, PhD

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 IIB or III colorectal cancer as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery.

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 IIB or III (UICC Sixth version) colorectal cancer/histological curability A (Japanese Classification of Colorectal Carcinoma, Sixth version) as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery.

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

Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Associate Director of Surgery, Osaka National Hospital

Rare Diseases

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

TS-1 Group: The group treated with TS-1 mono-therapy

TS-1+PSK Group: The group treated with combination therapy using TS-1 and PSK

From 4-8 weeks after surgery to 27-31 weeks after surgery, 80 mg/m2, PO from day 1 to day 14 of each 21 day cycle. Number of Cycles: 8 From 28-32 weeks after surgery to 53-57 weeks after surgery, 80 mg/m2, PO from day 1 to day 14 of each 28 day cycle. Number of Cycles: 7

Tegafur-gimeracil-oteracil potassium (TS-1)

From 4-8 weeks after surgery to 53-57 weeks after surgery, 3 g/day, PO every day

Koichi Miwa, MD, PhD

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 to examine or validate the outcome, QOL and prognostic factors (host and tumor factors), and explore the factors enhancing the antitumor effect of TS-1.

The 5-year survival after gastric cancer surgery remains poor as the cancer advances to stages II, IIIA, IIIB and IV. Tegafur-gimeracil-oteracil potassium (TS-1) is used as the first line treatment for advanced and recurrent gastric cancer. But TS-1 is accompanied by an adverse drug reaction of bone marrow suppression that is not readily seen in conventional oral fluoropyrimidines. Among randomized controlled trials on postoperative adjuvant chemotherapy for gastric cancer, the beneficial results of survival rates using Krestin (PSK) in combination with chemotherapy have been reported. With the objective to enhance the antitumor effect of TS-1 and to improve the QOL of patients, we have planned to validate the clinical significance of combined PSK and TS-1 therapy as postoperative adjuvant therapy for gastric cancer, using in principle the TS-1 regimen of 2-week dosing 1-week off for 6 months followed by 2-week dosing 2-week off for 6 months.

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

Randomized Multicenter Controlled Phase III Study of Postoperative Adjuvant Therapy for Stage II/IIIA Gastric Cancer Using TS-1 Alone or TS-1+PSK Combined Therapy

Hokuriku-Kinki Immunochemotherapy Study Group

Assistant Professor of Gastroenterologic Surgery, Kanazawa University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer	NCT00385970	Colorectal Canc...	Tegafur-uracil ... Calcium folinat... Krestin (PSK)	20 Years - 80 Years	Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK	NCT00216034	Gastric Cancer	Tegafur-gimerac... Krestin (PSK)	20 Years - 80 Years	Hokuriku-Kinki Immunochemotherapy Study Group
A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer	NCT00385970	Colorectal Canc...	Tegafur-uracil ... Calcium folinat... Krestin (PSK)	20 Years - 80 Years	Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer	NCT00385970	Colorectal Canc...	Tegafur-uracil ... Calcium folinat... Krestin (PSK)	20 Years - 80 Years	Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Spots Global Cancer Trial Database for krestin (psk)