A randomized phase II trial of adjuvant therapy with S-1 plus Hotyu-ekki-to (TJ41) versus S-1 alone for stage II/III gastric cancer
- Conditions
- Stage II or III gastric cancer
- Registration Number
- JPRN-UMIN000004701
- Lead Sponsor
- Department of Surgery Graduate School of Medicine, Kyoto University
- Brief Summary
Results: We randomly assigned 56 patients to group ST and 57 patients to group S. The completion rates of S-1 were 54.5 and 50.9%, the median relative dose intensities were 89.2 and 71.9%, and adverse events of grade 3 or 4 occurred in 45.5 and 54.5% in groups ST and S, respectively. There was no significant difference in 3-year OS or RFS between the two groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 113
Not provided
(1)Patient with active double cancer (synchronous double cancer and metachronous double cancer), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment. (2)Patient who was diagnosed as cStage IV at any time during preoperative treatment (3)Patient with administration contraindication of S-1 (4)Patient with regular use of H2-blocker, proton pump inhibitor, flucytosine, phenytoin, or warfarin.(5)Patients with past history of severe allergic reactions. (6)Patient with severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, or uncontrollable diabetes mellitus, heart failure, renal failure, or liver cirrhosis (7)Severe watery diarrhea. (8)Pregnant or nursing patient or with intent to bear baby (9) Men with partner willing to get pregnant (10)Exclude patients who are recognized as inadequate patients by doctors with responsibility in this trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method