Folfiri as Third Line of Treatment

IRCCS Cancer Referral Center of Basilicata26 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Gastric Cancer Ramucirumab Third Line

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

response rate (confirmed complete and partial response).

rate of patients with complete or partial response

Time frame: From date of enrollment to best radiological evaluation, up to 12 months

Secondary Outcomes

Progression free survival

Time from start of treatment to Progression or death

Time frame: 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

Overall survival

Time from start of treatment to Death for any cause

Time frame: From date of enrollment until the date of death from any cause, whichever came first, assessed up to 12 months

Toxicity

Incidence of Toxicity according National Cancer Institute Common Terminology Criteria

Time frame: From date to start therapy up to 12 months

Data from ClinicalTrials.gov

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