Folfiri as Third Line of Treatment

FOLFIRI as a Second-line Therapy in Patients With Docetaxel-pretreated Gastric Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03486379

Enrollment

Registered

2018-04-03

Start date

2016-03-31

Completion date

2018-03-23

Last updated

2018-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Ramucirumab, Third Line

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results