Gastric CancerNCT03486379
Folfiri as Third Line of Treatment
An observational study of Gastric Cancer and Ramucirumab, run by IRCCS Cancer Referral Center of Basilicata.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Ramucirumab, Third Line
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to 23 Mar 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic gastric cancer progressed after two lines of treatment including ramucirumab-based therapy.
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
About this study
Official title: FOLFIRI as a Second-line Therapy in Patients With Docetaxel-pretreated Gastric Cancer
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
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate (confirmed complete and partial response).
rate of patients with complete or partial response
Measured: From date of enrollment to best radiological evaluation, up to 12 months
Secondary outcomes (3)
Progression free survival
Time from start of treatment to Progression or death
Measured: 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
Measured: 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
Measured: From date to start therapy up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study startMar 2016
- Primary completion30 Sep 2017
- Study completion23 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- IRCCS Cancer Referral Center of Basilicata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giandomenico Roviello, IRCCS Cancer Referral Center of Basilicata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486379
- Sponsor's protocol ID
- IRCCS-CROB
- Status last verified
- Mar 2018
- First submitted
- 23 Mar 2018
- Last updated
- 3 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOLFIRI as a Second-line Therapy in Patients With Docetaxel-pretreated Gastric Cancer
- ClinicalTrials.gov ID
- NCT03486379
- Acronym / sponsor ID
- IRCCS-CROB
- Conditions
- Gastric Cancer, Ramucirumab, Third Line
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- IRCCS Cancer Referral Center of BasilicataUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic gastric cancer progressed after two lines of treatment including ramucirumab-based therapy.
Key inclusion criteria (10 listed)
- 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),
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
response rate (confirmed complete and partial response).
Time frame: From date of enrollment to best radiological evaluation, up to 12 months
rate of patients with complete or partial response
3 secondary outcomes
Progression free survival
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 frame: From date of enrollment until the date of death from any cause, whichever came first, assessed up to 12 months
Toxicity
Time frame: From date to start therapy up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Ramucirumab, run by IRCCS Cancer Referral Center of Basilicata.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (confirmed complete and partial response). (time frame: From date of enrollment to best radiological evaluation, up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.