NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000138

Registered date:08/09/2005

Randomized phase II study of best available 5-FU versus low-dose Paclitaxiel in gastric cancer with peritoneal metastasis refractory to 5-FU containing regimen(JCOG0407)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedgastric neoplasm
Date of first enrollment2005/09/01
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A: Best available 5-FU In the best available 5-FU arm, 5-FU continuous infusion (5-FUci) regimen or sequential methotrexate (MTX) and 5-fluorouracil (MTX/5-FU) regimen is selected according to patients' prior chemotherapy: If the prior chemotherapy included 5-FU bolus infusion or MTX, 5-FUci regimen will be selected. The other cases select MTX/5-FU regimen. The 5-FUci regimen consists of 5-FUci (800 mg/m2/day, days 1 through 5), every 4 weeks. The MTX/5-FU regimen consists of MTX bolus infusion (100 mg/m2/day, day 1), 5-FU bolus infusion (600 mg/m2/day, day 1) after MTX, and l-leucovorin administration by oral or infusion (10 mg/m2/6 hour, days 2 through 3), which are repeated weekly. B: Low dose paclitaxel The low-dose paclitaxel regimen consists of 1-hour paclitaxel infusion (80 mg/m2/day, days 1, 8, and 15) every 4 weeks.

Outcome(s)

Primary Outcomeoverall survival
Secondary Outcomeadverse events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria(1) they have histologically proven recurrence or unresectable gastric adenocarcionoma (2) they have peritoneal metastasis (3) they have no symptomatic central nerve system metastasis (4) they are aged 20-75 years (5) they have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 (6) In recurred cases, they had received fluoropirimidine analogs containing regimen as adjuvant chemotherapy. The period from last administration of adjuvant chemotherapy should be within 24 days. In unresectable cases, they had received fluoropirimidine analogs containing regimen as 1st line chemotherapy. The period from last administration of 1st line chemotherapy should be within 6 weeks. The fluoropirimidine analogs containing regimen is as follows: fluorouracil (5-FU), uracil and tegafur (UFT), tegafur, gimeracil, oteracil potassium (TS-1), 1-hexylcarbamoyl-5-fluorouracil (HCFJ), tegafur, 5'-DFUR;doxifluridine (FT) (7) their prior chemotherapy did not include taxanes nor bolus infusion and continuous infusion of 5-FU (i.e., FOLFOX, FOLFILI, FAMTX, or ECF) (8) they have sufficient organ function (9) they have no history of gastrointestinal surgery (10) they have no history of chemotherapy except for gastric cancer (11) they have no history of radiotherapy for any malignancy (12) they provided written informed consent
Exclude criteria(1) diabetes mellitus, uncontrolled or controlled with insulin (2) unstable angina, or myocardial infarction within 6 months prior to the study (3) arrhythmia, needing medical intervention (4) hypersensitivity to alcohol (5) HBs antigen or their HCV antibody are positive (6) massive pleural effusion (7) Grade 3-4 diarrhea (CTCAE ver3.0) (8) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ (9) pregnant or lactating women (10) severe mental disease (11) not appropriate for the trial at the physician's assessment

Related Information

Contact

public contact
Name Hiroya Takiuchi, MD, PhD
Address 2-7 daigakumachi, takatuki-shi, Osaka, 569-8686, JAPAN Japan
Telephone
E-mail JCOG_sir@ml.jcog.jp
Affiliation JCOG0407 coordinating Office Second Department of Internal Medicine,Osaka Medical College
scientific contact
Name Hiroya Takiuchi, MD, PhD
Address 2-7 daigakumachi, takatuki-shi, Osaka, 569-8686, JAPAN Japan
Telephone
E-mail
Affiliation Osaka Medical College Second Department of Internal Medicine