A Phase II study to confirm the effectiveness of TS-1 plus docetaxel for aged patients with advanced and/or metastatic gastric cancer (OGSG 0902)

Phase 2

• Conditions: advanced and/or metastatic gastric cancer

• Registration Number: JPRN-UMIN000002785
• Lead Sponsor: Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-19
• Study Completion: 2016-01-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with active double cancers 2) Any other serious illness or medical condition(s) including ileus, intestinal obstruction, uncontrolled DM, interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, etc. 3) Patients with ascites and/or pleural fluid 4) Patients with any symptoms due to metastases to the central nervous system 5) Patients with any fresh bleeding from digestive tract 6) with severe ischemic cardiac diseases or arythmia which needs treatments 7) Patients with interstitial pneumonia or pulmonary fibrosis diagnosed by chest X ray and/or CT 8) History of serious drug hypersensitivity due to 5-FU, Docetaxel or Polysolbate 80 9) Patients with severe dysfunction of kidney, bone marrow and/or liver 10) Patients who need flucitosine, fenitoin or walfarin 11) Patients with untreated edema 12) Any other patient whom the physician in charge of the study judges to be unsuitable.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response Rate (RECIST)

Secondary Outcome Measures

Name	Time	Method
Adverse Events/Incidence of AE. Overall survival Progression Free Survival Time to Treatment Failure