Folfiri as Third Line of Treatment

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03486379
• Other study ID #: IRCCS-CROB
• Status: Completed
• First received: March 23, 2018
• Last updated: March 30, 2018
• Start date: March 2016
• Est. completion date: March 23, 2018

Study information

• Verified date: March 2018
• Source: IRCCS Cancer Referral Center of Basilicata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 23, 2018
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Ramucirumab
• Stomach Neoplasms
• Third Line

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Cancer Referral Center of Basilicata

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate (confirmed complete and partial response).	rate of patients with complete or partial response	From date of enrollment to best radiological evaluation, up to 12 months
Secondary	Progression free survival	Time from start of treatment to Progression or death	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
Secondary	Overall survival	Time from start of treatment to Death for any cause	From date of enrollment until the date of death from any cause, whichever came first, assessed up to 12 months
Secondary	Toxicity	Incidence of Toxicity according National Cancer Institute Common Terminology Criteria	From date to start therapy up to 12 months