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NCT02481336 - To Study the Individual Variants of Chemotherapy-Induced Neurotoxicity

Official Title
Integrating Clinical and Genomic Profiles for Prediction and Prevention of Chemotherapy-induced Neuropathy Via Big Bio-Data Analytics
Brief Title
To Study the Individual Variants of Chemotherapy-Induced Neurotoxicity
Protocol ID
NCT02481336
Lead Sponsor
National Cheng-Kung University Hospital
Brief Summary
To study the risk prediction of chemotherapy-induced peripheral neuropathy (CIPN) by the clinical bioinformatics and genomic profile.
Detailed Description
This is a prospective, observational, cohort study, monitoring the chemotherapy-induced peripheral neurotoxicity by traditional clinical scales, neurological examinations, and semi-quantitative assessments. Moreover, all the genetic changes will be analyzed by next generation sequencing and we will try to identify relevant variants in individuals who suffer from chemotherapy-induced neurotoxicity.
Enrollment Count
300 participants
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed epithelial ovarian cancer, endometrial cancer or adenocarcinoma of colon or rectum 2. Pathological stage I~IV for ovarian cancer, stage II~IV endometrial cancer or stage III & high risk stage II for colorectal cancer 3. Scheduled to receive adjuvant Paclitaxel/Carboplatin for ovarian or endometrial cancer, or mFOLFOX6 for colorectal cancer 4. Age ≥ 20 years old 5. ECOG Performance status 0-1 6. Adequate organ function Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L WBC ≥ 3.0 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin ≥ 9 g/dL Hepatic: Total bilirubin level ≤ 1.0 x UNL AST and ALT ≤ 3.0 x UNL Renal: Creatinine level ≤ 1.5 mg/dL in men, ≤1.4 mg/dL in women; or Estimated CCr ≥ 60 mL/min (CCr is estimated by Cockcroft-Gault formula, as appendix III). 7. Negative pregnancy test for women of childbearing potential only 8. Patient willing to provide blood sample for research purposes 9. Written informed consent Exclusion Criteria: 1. Prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin, carboplatin, taxanes or vinca alkaloids 2. Receiving chemotherapy within 6 months 3. History of allergy to 5-FU or LV 4. Pre-existing peripheral neuropathy of any grade 5. A family history of a genetic or familial neuropathy 6. Active uncontrolled infection 7. Significant medical diseases, such as unstable angina, acute or recent myocardial infarction (<6 months before enrollment), COPD with frequent exacerbation, uncontrolled hypertension, ore cent CVA (<6 months before enrollment) 8. Poor compliance
Filters
Neurotoxicity Syndromes
ACTIVE_NOT_RECRUITING
ADULT
OLDER_ADULT