Folfiri as Third Line of Treatment

Completed

• Conditions: Third Line; Ramucirumab; Gastric Cancer

• Registration Number: NCT03486379
• Lead Sponsor: IRCCS Cancer Referral Center of Basilicata

Brief Summary

The aim of this study is to investigate the activity of Folfiri as Third line of treatment in mGC progressed after ramuciramb-based second line.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2017-09-30
• Status Verified: 2018-03
• Study Completion: 2018-03-23
• Study First Submitted: 2018-03-23
• Study First Submitted QC: 2018-03-30
• Last Update Submitted: 2018-03-30
• Study First Posted: 2018-04-03
• Last Update Posted: 2018-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Patients with histologically confirmed, ramucirumab pretreated metastatic gastric cancer who received
• Eastern Cooperative Oncology Group performance status ≤2 (ECOG PS)
• aged > 18 years
• neutrophil count ≥1500/μl
• platelet count ≥100 000/μl),
• renal (serum creatinine ≤1.5 mg/dl)
• liver (serum bilirubin ≤2 mg/dL) functions
• normal cardiac function,
• absence of second primary tumor other than non-melanoma skin cancer
• no concurrent uncontrolled medical illness.

Exclusion Criteria

• Eastern Cooperative Oncology Group performance status >2 (ECOG PS)
• No prior treatment with ramucirumab
• operable metastatic disease were excluded from the study
• severe cardiac dysfunction, congestive heart failure or a recent myocardial infarction
• uncontrolled sites of infection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
response rate (confirmed complete and partial response).	From date of enrollment to best radiological evaluation, up to 12 months	rate of patients with complete or partial response

Secondary Outcome Measures

Name	Time	Method
Progression free survival	From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months	Time from start of treatment to Progression or death
Overall survival	From date of enrollment until the date of death from any cause, whichever came first, assessed up to 12 months	Time from start of treatment to Death for any cause
Toxicity	From date to start therapy up to 12 months	Incidence of Toxicity according National Cancer Institute Common Terminology Criteria