Predicting Peripheral Neuropathy of Paclitaxel for Gastric Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorCity of Hope Medical Center
About this trial
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 by identifying patients at high risk for side effects. Although paclitaxel-based therapy is the standard second-line treatment, peripheral neuropathy is a troublesome adverse event. The purpose of this study is to establish a liquid biopsy assay to predict paclitaxel-induced peripheral neuropathy in gastric cancer patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients need second-line chemotherapy with unresectable or recurrent Gastric cancer.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Paclitaxel
DrugGastric cancer second-line chemotherapy
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Patients with peripheral neuropathy of paclitaxel in second-line chemotherapy for gastric cancer1 intervention
Group B: Patients without peripheral neuropathy of paclitaxel in second-line chemotherapy for gastric cancer1 intervention
Trial outcomes
Primary outcomes
1
Incidence of peripheral neuropathy
The standard approach to treatment-related adverse events that occur during anticancer treatment is the Common Terminology Criteria for Adverse Events (CTCAE), which is maintained by the US National Cancer Institute.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov