Predicting Peripheral Neuropathy of Paclitaxel for Gastric Cancer

Launched by CITY OF HOPE MEDICAL CENTER · Jul 3, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how to predict a specific side effect called peripheral neuropathy that can occur in patients with gastric cancer who are being treated with a chemotherapy drug called paclitaxel. Peripheral neuropathy can cause symptoms like tingling, numbness, or pain in the hands and feet, which can be quite uncomfortable. The researchers aim to develop a simple blood test, known as a liquid biopsy, that will help identify patients who are at a higher risk of experiencing this side effect, allowing for more personalized treatment plans.

To participate in this study, individuals must be at least 20 years old and have a confirmed diagnosis of advanced gastric cancer that cannot be surgically removed or has come back after treatment. They should also have had a first-line chemotherapy that included certain drugs but are now experiencing disease progression or cannot tolerate that treatment anymore. Participants will be monitored throughout the study, and they will need to provide informed consent, meaning they will be fully informed about the study and agree to take part. It's important for potential participants to discuss their health history with their doctors to ensure they meet the criteria for joining the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. unresectable or recurrent Gastric cancer (GC) histologically confirmed to be primary adenocarcinoma of the stomach.
• • 2. age over 20 years.
• • 3. Eastern Cooperative Oncology Group performance status score of 0-2.
• • 4. written informed consent following full study information is provided to the patient.
• • 5. progression or intolerance for first-line chemotherapy comprising fluorinated pyrimidine and platinum anticancer drugs (cisplatin or oxaliplatin) for advanced GC.
• • 6. presence of evaluable lesions as confirmed using a computed tomography (CT) or magnetic resonance imaging.
• Exclusion Criteria:
• • 1. Patients with a life expectancy of shorter than 3 months
• • 2. Patients with severe complications (angina pectoris, myocardial infarction, or arrhythmia) or uncontrollable diabetes mellitus, blood hypertension, or bleeding tendency.
• • 3. Patients with a history of serious allergic reactions or serious drug allergy.
• • 4. Patients with a clinically relevant mental disorder that prohibits response to questionnaires.
• • 5. Patients for whom the attending physician considered that enrollment in the study is inappropriate.