Clinical trial 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Neurotoxicity Syndromes
Keywords: Chemotherapy
Peripheral Neuropathy
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Total 300 cancer patients will be enrolled in National Cheng Kung University Hospital from March, 2015 to March, 2017. The subjects are stage I-IV ovarian cancer patients receiving chemotherapy Paclitaxel/Carboplatin, stage II-IV endometrial cancer patients receiving chemotherapy Paclitaxel/Carboplatin, stage III \& high risk stage II colorectal cancer patients receiving chemotherapy with mFOLFOX.

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.

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

Primary outcomes:
measure: Adverse events occurring after chemotherapy based on genomic profiling
timeFrame: up to 2 years after chemotherapy
Secondary outcomes:
measure: Changes in quality-of-life measured by EORTC CIPN20
timeFrame: up to 2 years after chemotherapy
measure: Changes in quality-of-life measured by EQ-5D-3L
timeFrame: up to 2 years after chemotherapy
measure: Change from Baseline in nerve conduction velocity (NCV)
timeFrame: up to 2 years after chemotherapy
measure: Change from Baseline in quantitative sensory test (QST)
timeFrame: up to 2 years after chemotherapy
measure: Change from Baseline in nerve excitability test (NET)
timeFrame: up to 2 years after chemotherapy
measure: Relapse-free survival
timeFrame: up to 5 years after chemotherapy
measure: Overall Survival
timeFrame: up to 5 years after chemotherapy
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng Kung University
name: Meng-Ru Shen, PHD
role: STUDY_CHAIR
References: