Predicting nerve damage from chemotherapy in gastric cancer patients
Predicting Peripheral Neuropathy of Paclitaxel in Second-line Chemotherapy for Gastric Cancer
This study is testing a new blood test to see if it can help predict which gastric cancer patients are at risk of nerve damage from chemotherapy, so doctors can tailor their treatment accordingly.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy, ramucirumab |
| Locations | 1 site (Kurashiki, Okayama-ken) |
| Trial ID | NCT06490159 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a liquid biopsy assay to predict the risk of peripheral neuropathy in gastric cancer patients undergoing paclitaxel-based second-line chemotherapy. Approximately 30-40% of these patients experience this adverse effect, which can significantly impact their quality of life and treatment adherence. By identifying high-risk patients prior to treatment, the study seeks to enable personalized treatment strategies, such as dose adjustments or alternative therapies. The study will involve patients with unresectable or recurrent gastric cancer who have previously undergone first-line chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults over 20 years old with unresectable or recurrent gastric cancer who have experienced progression or intolerance to first-line chemotherapy.
Not a fit: Patients with a life expectancy of less than three months or those with severe complications or mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help tailor chemotherapy regimens to minimize the risk of debilitating side effects for gastric cancer patients.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for predicting chemotherapy side effects, indicating that this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kurashiki, Okayama-ken
- Kawasaki Medical University — Kurashiki, Okayama-ken, Japan (Recruiting)
Study contacts
- Principal investigator: Koichi Takiguchi, PhD — City of Hope Medical Center
- Study coordinator: Ajay Goel, PhD
- Email: AJGOEL@COH.ORG
- Phone: 6262183452
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.