Status:
RECRUITING
Predicting Peripheral Neuropathy of Paclitaxel for Gastric Cancer
Lead Sponsor:
City of Hope Medical Center
Conditions:
Gastric Cancer
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
20+ years
Brief Summary
Although advances in chemotherapy have improved the prognosis of gastric cancer patients, many patients still suffer from adverse events. Therefore, it is necessary to establish personalized treatment...
Detailed Description
Paclitaxel-based therapy is the standard second-line treatment for gastric cancer patients, but approximately 30-40% of patients develop peripheral neuropathy that interferes with daily life, and abou...
Eligibility Criteria
Inclusion
- unresectable or recurrent Gastric cancer (GC) histologically confirmed to be primary adenocarcinoma of the stomach.
- age over 20 years.
- Eastern Cooperative Oncology Group performance status score of 0-2.
- written informed consent following full study information is provided to the patient.
- progression or intolerance for first-line chemotherapy comprising fluorinated pyrimidine and platinum anticancer drugs (cisplatin or oxaliplatin) for advanced GC.
- presence of evaluable lesions as confirmed using a computed tomography (CT) or magnetic resonance imaging.
Exclusion
- Patients with a life expectancy of shorter than 3 months
- Patients with severe complications (angina pectoris, myocardial infarction, or arrhythmia) or uncontrollable diabetes mellitus, blood hypertension, or bleeding tendency.
- Patients with a history of serious allergic reactions or serious drug allergy.
- Patients with a clinically relevant mental disorder that prohibits response to questionnaires.
- Patients for whom the attending physician considered that enrollment in the study is inappropriate.
Key Trial Info
Start Date :
October 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 18 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06490159
Start Date
October 1 2018
End Date
June 18 2026
Last Update
July 11 2025
Active Locations (1)
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1
Kawasaki Medical University
Kurashiki, Okayama-ken, Japan, 7010192