Predictive Role of Circulating Angiogenic Factors for Second-line Paclitaxel and Ramucirumab.

NCT05301465 | Unknown

• 1 other identifier: PREDICTOR
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression Free Survival

  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.

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 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

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University of Pisa

Pisa, 56126, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples

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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 29, 2022
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: June 1, 2023
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

IT (1)