Randomized phase III study of TS-1 alone versus TS-1 plus Lentinan(LNT) in advanced or recurrent gastric cancer (AGC)

Phase 3

• Conditions: Advanced or recurrent gastric cancer (AGC)

• Registration Number: JPRN-UMIN000000574
• Lead Sponsor: Japanese Foundation for Multidisciplinary Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1) Histologically demonstrated adenocarcinoma of advanced or recurrent gastric carcinoma
2) If measurable lesions exist, these have to be evaluated within 28 days before registration
3) No prior therapy
4) Sufficient organ functions
5) Performance Status (ECOG scale) : 0-2
6) Expected survival over 3 months
7) Oral intake is possible
8) Written informed consent

Exclusion Criteria

1) Limitation of use of TS-1 or Lentinan
2) Infection and inflammation
3) Serious heart disease
4) Serious coexisting illness
5) A large amount of pleural effusion or peritoneal fluid
6) Broad bone metastasis
7) Brain metastasis
8) Fresh bleeding from digestive organs
9) Diarrhea
10) Severe mental disorders
11) Active synchronous malignancy
12) Pregnant or nursing
13) Not suitable for participating in this study for any other reason

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival

Secondary Outcome Measures

Name	Time	Method
TTF, adverse events, QOL, tumor response