Folfiri as Third Line of Treatment

NCT03486379 | Completed

• 1 other identifier: IRCCS-CROB
• Study Type: observational
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastric Cancer; Ramucirumab; Third Line

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Overall survival

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

• Toxicity

  From date to start therapy up to 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic gastric cancer progressed after two lines of treatment including ramucirumab-based therapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Cancer Referral Center of Basilicata: lead

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MS, PhD

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 3, 2018
• Study Start: March 1, 2016
• Primary Completion: September 30, 2017
• Study Completion: March 23, 2018
• Last Updated: April 3, 2018

Record last verified: 2018-03