Folfiri as Third Line of Treatment | NCT03486379

Studies
Folfiri as Third Line of Treatment

NCT03486379

Sponsor

IRCCS Cancer Referral Center of Basilicata

Status

Completed

Last Update Posted

Apr 3, 2018Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Gastric Cancer
Ramucirumab
Third Line

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Sep 30, 2017Actual

Completion Date

Mar 23, 2018Actual

First Submitted Date

Mar 23, 2018

First Submission Date that Met QC Criteria

Mar 30, 2018

First Posted Date

Apr 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2018

Last Update Posted Date

Apr 3, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giandomenico Roviello, MS, PhD, IRCCS Cancer Referral Center of BasilicataPrincipal Investigator

Lead Sponsor

IRCCS Cancer Referral Center of BasilicataOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided