Phase II Study of Docetaxel and S-1 Combination Therapy for Advanced or Recurrent Gastric Cancer

Phase II Study of Docetaxel and S-1 Combination Therapy for Advanced or Recurrent Gastric Cancer - Phase II Study of Docetaxel and S-1 Combination Therapy for Advanced or Recurrent Gastric Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000103

Enrollment

Registered

2005-10-01

Start date

2002-08-01

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

Metastatic gastric cancer (Advanced or recurrent gastric cancer)

Interventions

Intravenous administration of 40 mg/m2 docetaxel on Day 1 and oral administration of 80 mg/m2/day S-1 on Days 1 to 14 every 3 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)With pathologically proven gastric cancer (2)With at least one measurable lesion (RECIST) (3)With advanced or recurrent gastric cancer (4)No prior chemotherapy or 1 regimen that was completed >=28 days prior to entry (5)ECOG performance status=12 weeks (7)With adequate bone marrow, cardiac, respiratory, hepatic, and renal functions. Defined as: white blood cell count>=4000 mm3=2000 mm3, hemoglobin>=9.0 g/dl, platelet>=100,000 mm3, AST and ALT within two times the upper limit of normal for the institution, serum bilirubin level=50 ml/min. (8)age 20-75 years (9)With written informed consent

Exclusion criteria

Exclusion criteria: 1)Symptomatic infectious disease 2)Accompanied serious diseases such as pulmonary fibrosis, interstitial pneumonia, and symptomatic bleeding tendency 3)Peripheral neuropathy>=grade 2 4)Edema>=grade 2 5)Active secondary cancer 6)Symptomatic pleural effusion or ascites 7)Pregnancy or breast feeding 8)Obstructive bowel disease 9)Concomitant therapy with another anticancer drug or flucytocine 10)Past history of allergic reaction to polysorbate 80 11)A past history of drug allergy 12)A past history of allergic reaction to alcohol 13)Symptomatic psychological disease, or uncontrollable diabetes 14)Hemorrhage/bleeding>=grade 3 (NCI-CTC) 15)Decision as ineligible by principal investigator

Design outcomes

Primary

Measure	Time frame
Tumor response rate	—

Secondary

Measure	Time frame
1)Adverse events, 2)Progression free-survival (PFS) 3)Median overall survival (MST)	—

Countries

Japan

Contacts

Public ContactMasahiko Nishiyama

Research Institute for Radiation Biology and Medicine, Hiroshima University Department of Translational Cancer Research

yamacho@hiroshima-u.ac.jp082-257-5839

Outcome results

None listed

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