A phase II trial of TS-1 and weelky CDDP combined with hyperthermia as therapy of advanced and relapsed gastric cancer

A phase II trial of TS-1 and weelky CDDP combined with hyperthermia as therapy of advanced and relapsed gastric cancer - Combination therapy of TS-1, weekly CDDP, and hyperthermia in advanced and relapsed gastric cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002823

Enrollment

Registered

2009-12-03

Start date

2009-09-01

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

Advanced and relapsed gastric cancer

Interventions

TS-1/weekly CDDP plus hyperthermia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligible criteria in this study are as follows: 1.Histologically confirmed unresectable/relapsed gastic cancer 2.Existing measurable lesion 3.No prior treatment 4.PS is 0, 1 or 2 5.Over 20, and under 80 years of age 6.Sufficient functions of main organ 7.More than 3 months of expected survival period 8.Written informed consent

Exclusion criteria

Exclusion criteria: 1. TS-1 or CDDP is contraindicated drug 2. With active infection or inflammation 3. With severe heart failure 4. Severe complications 5. With large amout of ascites or pleural effusion 6. With bone metastasis 7. With brain metastasis 8. Active gastrointestinal bleeding needing blood infusion 9. With diarrhea 10.Under treatment with antipsychotic tranquilizer 11. With active double cancer 12.Pregnant or nursing women 13.Men who like be pregnant 14.Inappropriate patients for this study judged by the physicians

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Safety, Overall survival, Progression-free survival time	—

Countries

Japan

Contacts

Public ContactSatoshi Kokura

Molecular Gastroenterology and Hepatology Molecular Gastroenterology and Hepatology

s-kokura@koto.kpu-m.ac.jp075-251-5519

Outcome results

None listed

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