NCT06490159 Predicting Peripheral Neuropathy of Paclitaxel for Gastric Cancer
| NCT ID | NCT06490159 |
| Status | Recruiting |
| Phase | — |
| Sponsor | City of Hope Medical Center |
| Condition | Gastric Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2018-10-01 |
| Primary Completion | 2028-06-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2018-10-01 with a primary completion date of 2028-06-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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.
Contact & Investigator
Koichi Takiguchi, PhD
PRINCIPAL INVESTIGATOR
City of Hope Medical Center
Frequently Asked Questions
Who can join the NCT06490159 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06490159 currently recruiting?
Yes, NCT06490159 is actively recruiting participants. Contact the research team at AJGOEL@COH.ORG for enrollment information.
Where is the NCT06490159 trial being conducted?
This trial is being conducted at Kurashiki, Japan.
Who is sponsoring the NCT06490159 clinical trial?
NCT06490159 is sponsored by City of Hope Medical Center. The principal investigator is Koichi Takiguchi, PhD at City of Hope Medical Center. The trial plans to enroll 150 participants.
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