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)

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) - 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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000138

Enrollment

100

Registered

2005-09-08

Start date

2005-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric neoplasm

Interventions

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 patien

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
adverse events	—

Countries

Japan

Contacts

Public ContactHiroya Takiuchi, MD, PhD

JCOG0407 coordinating Office Second Department of Internal Medicine,Osaka Medical College

JCOG_sir@ml.jcog.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026