Status:
UNKNOWN
Predictive Role of Circulating Angiogenic Factors for Second-line Paclitaxel and Ramucirumab.
Lead Sponsor:
University of Pisa
Conditions:
Gastric Cancer Stage IV
Eligibility:
All Genders
18+ years
Brief 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 gr...
Eligibility Criteria
Inclusion
- 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);
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05301465
Start Date
November 1 2021
End Date
June 1 2023
Last Update
March 29 2022
Active Locations (1)
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1
University of Pisa
Pisa, Italy, 56126