Phase II trial of bolus 5-FU/l-LV regimen as salvage line chemotherapy for oral fluorouracil resistant unresectable gastric cancer (HGCSG1502)

Phase 2

• Conditions: Gastric Cancer or Cancer at the Esophagogastric Junction

• Registration Number: JPRN-UMIN000018882
• Lead Sponsor: Hokkaido University Hospital Cancer Center

Brief Summary

Among the 29 enrolled patients, PFS rate at 8 weeks was 55.2% (95% CI 35.6% to 71.0%), which was higher than 47.5% which is the expected value of the hypothesis, and the lower limit of 95% CI is significantly higher than the threshold which is 23.1%. Grade 3 to 4 hematological adverse events (AE) were as follows; anemia 20.7%, neutropenia 3.4%, and platelet count decreased 3.4%. Grade 3 to 4 non-hematological AE were observed as follows; anorexia 20.7%, fatigue 13.8%, and diarrhea 3.4%.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-01
• Study Completion: 2018-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

1. patients with symptomatic central nerve metastasis 2. patients with uncontrolled active infection 3. patients with uncontrollable diarrhea 4. patients with uncontrollable ischemic heart disease 5. patients with ascites that requires frequent drainage 6. patients with intestinal obstruction condition requiring sustained drainage by long tube 7. patients with other serious complications not to be able to be given anti-cancer chemotherapy 8. Patients with other overlapping malignancies that can be a prognostic factor. 9. patients with difficulty to their decision-making with severe mental disorders to be estimated. 10. pregnant, or female patients with intention of lactating and pregnancy and childbirth. 11. Male patients who are willing to let the pregnancy. 12. patients using flucytosine. 13. Patients who have undergone bolus 5-FU containing anti-cancer chemotherapy in the past for their gastric cancer. 14.S-1 and capecitabine last administration day within seven days. 15. patient during radiation therapy. 16. Other, patients attending physician has determined unsuitable for the target of the study treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival rate at the time the treatment after 8 weeks

Secondary Outcome Measures

Name	Time	Method
response rate, disease control rate, overall survival, progression free survival, time to treatment failure, adverse events, dose intensity and QOL by EORTC QLQ-C30