Gastric Cancer Stage IVNCT05301465
Predictive Role of Circulating Angiogenic Factors for Second-line Paclitaxel and Ramucirumab.
An observational study of Gastric Cancer Stage IV, run by University of Pisa at 1 site in Italy.
Trial summary
The project is primarily aimed at identifying and subsequently validating the predictive role of plasma concentrations of VEGF-A (vascular endothelial growth factor A), VEGF-D (vascular endothelial growth factor D) and s-VEGFR2 (soluble Vascular Endothelial Growth Factor Receptor 2) measured prior to initiation and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer Stage IV
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2021to 1 Jun 2023
- 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 enrolled are affected by metastatic gastro-oesophageal junction or stomach cancer, undergoing second-line treatment with the combination of paclitaxel and ramucirumab according to normal clinical practice
Who may be able to join
- Histologically confirmed carcinoma of the stomach, cardia or gastroesophageal junction;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1;
- Life expectancy >3 months;
- Age >18 years;
- Metastatic disease measurable or evaluable according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1;
- Progression after previous first-line treatment with fluoropyrimidines and platinum derivative; previous neoadjuvant/adjuvant treatment terminated ≤6 months after instrumental evidence of relapse will be considered first-line treatment;
- Prior treatment with trastuzumab in case of HER-2 (human epidermal growth factor receptor 2) positive disease, defined as a 3+ immunohistochemistry (IHC) or 2+ IHC score and subsequent gene amplification demonstrated by Fluorescent In Situ Hybridization (FISH);
Who cannot join
- Previous treatment with ≥2 lines of systemic therapy for metastatic disease;
- Symptomatic peripheral neuropathy ≥2 grades according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03;
- Uncontrolled infections in active phase, disseminated intravascular coagulation in activity;
- Clinically significant cardiovascular disease, such as cardiovascular accidents (less than 6 months after initiation of treatment), myocardial infarction (less than 6 months after initiation of treatment), unstable angina, chronic heart failure ≥2 New York Heart Association (NYHA) grade, uncontrolled arrhythmias;
- Past (within 2 years of treatment initiation, except for curatively treated basal or squamous cell carcinomas of the skin or carcinoma in situ of the cervix) or current history of malignancy other than gastric cancer.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Pisa
Pisa, 56126
Gianluca Masi, M.D, 0039050992466, gianluca.masi@unipi.it
Lorenzo Fornaro, M.D., 0039050992466, l.fornaro@ao-pisa.toscana.it
About this study
Official title: Prospective Study to Identify and Validate the Predictive Role of Circulating Angiogenic Factors in Patients With Metastatic Gastric Cancer Treated With Second-line Paclitaxel and Ramucirumab
The project is primarily aimed at identifying and subsequently validating the predictive role of plasma concentrations of VEGF-A (vascular endothelial growth factor A), VEGF-D (vascular endothelial growth factor D) and s-VEGFR2 (soluble Vascular Endothelial Growth Factor Receptor 2) measured prior to initiation and during second-line treatment with paclitaxel and ramucirumab in patients with unresectable gastric cancer pretreated with first-line chemotherapy.
For the primary endpoint, the efficacy parameter chosen is PFS, calculated from day 1 of treatment to date of progression or death.
- Conditions
- Gastric Cancer Stage IV
- Keywords
- ramucirumab, gastric cancer, paclitaxel, predictive factors, VEGF
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression Free Survival
Measured: PFS is defined as the time interval between the start of second-line treatment and documentation of disease progression or death (whichever occurs first), assessed up to 6 months for each enrolled patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Nov 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer Stage IVStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Gianluca Masi, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301465
- Sponsor's protocol ID
- PREDICTOR
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Identify and Validate the Predictive Role of Circulating Angiogenic Factors in Patients With Metastatic Gastric Cancer Treated With Second-line Paclitaxel and Ramucirumab
- ClinicalTrials.gov ID
- NCT05301465
- Acronym / sponsor ID
- PREDICTOR
- Conditions
- Gastric Cancer Stage IV
- Keywords
- ramucirumab, gastric cancer, paclitaxel, predictive factors, VEGF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 29 Mar 2022 (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 project is primarily aimed at identifying and subsequently validating the predictive role of plasma concentrations of VEGF-A (vascular endothelial growth factor A), VEGF-D (vascular endothelial growth factor D) and s-VEGFR2 (soluble Vascular Endothelial Growth Factor Receptor 2) measured prior to initiation and during second-line treatment with paclitaxel and ramucirumab in patients with unresectable gastric cancer pretreated with first-line chemotherapy.
For the primary endpoint, the efficacy parameter chosen is PFS, calculated from day 1 of treatment to date of progression or death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled are affected by metastatic gastro-oesophageal junction or stomach cancer, undergoing second-line treatment with the combination of paclitaxel and ramucirumab according to normal clinical practice
Key inclusion criteria (7 listed)
- Histologically confirmed carcinoma of the stomach, cardia or gastroesophageal junction;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1;
- Life expectancy >3 months;
- Age >18 years;
- Metastatic disease measurable or evaluable according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1;
Key exclusion criteria (5 listed)
- Previous treatment with ≥2 lines of systemic therapy for metastatic disease;
- Symptomatic peripheral neuropathy ≥2 grades according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03;
- Uncontrolled infections in active phase, disseminated intravascular coagulation in activity;
- Clinically significant cardiovascular disease, such as cardiovascular accidents (less than 6 months after initiation of treatment), myocardial infarction (less than 6 months after initiation of treatment), unstable angina, chronic heart failure ≥2 New York Heart Association (NYHA) grade, uncontrolled arrhythmias;
- Past (within 2 years of treatment initiation, except for curatively treated basal or squamous cell carcinomas of the skin or carcinoma in situ of the cervix) or current history of malignancy other than gastric cancer.
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
PFS
Time frame: PFS is defined as the time interval between the start of second-line treatment and documentation of disease progression or death (whichever occurs first), assessed up to 6 months for each enrolled patient.
Progression Free Survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer Stage IV, run by University of Pisa at 1 site in Italy.
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 7 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: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: PFS is defined as the time interval between the start of second-line treatment and documentation of disease progression or death (whichever occurs first), assessed up to 6 months for each enrolled patient.). 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 29 Mar 2022.