DOS study

Phase I/II study of S-1, docetaxel, oxaliplatin combination chemotherapy in patients with HER2-negative unresectable metastatic gastric cancer - Phase I/II study of DOS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs061180095

Enrollment

Registered

2019-03-22

Start date

2017-06-26

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 cancer gastric cancer

Interventions

Docetaxel (50mg/m2) and oxaliplatin (80-130mg/m2) given on day 8, and S-1 (80mg/m2) given on days 1-14, repeated every three weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Written informed consent. 2)Histologicaly (cytologically) proven gastric cancer. 3)HER2 negative method 4)Unresectable gastric cancer. 5)To have evaluable lesions. 6)No prior chemotherapy or no influence of prior therapy. 7)Tolerable function of bone marrow, liver, and kidney. 8)PS 0 - 1. 9)Expected survival for three months. 10)Possible oral intake.

Exclusion criteria

Exclusion criteria: 1)History of hypersensitivity to DCS. 2)Contraindication to DTX, Oxaliplatin, S-1. 3)Infectious disease. 4)Severe complication. 5)Brain metastasis with clinical symptoms. 6)Watery diarrhea. 7)Active double cancer. 9)Persons to be pregnant or to make pregnant.

Design outcomes

Primary

Measure	Time frame
maximum tolerated dose(MTD), Dose-limiting toxicities (DLTs), Recommended dose (RD), Response rate (RR)	—

Secondary

Measure	Time frame
median survival time (OS), progression-free survival(PFS)	—

Contacts

Public ContactYasushi Sato

Tokushima University

sato.yasushi@tokushima-u.ac.jp+81-88-633-7124

Outcome results

None listed

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