To Study the Individual Variants of Chemotherapy-Induced Neurotoxicity

National Cheng-Kung University

Status: Active, not recruiting

Conditions: Neurotoxicity Syndromes

Treatments: Genetic: Whole Genome Sequence; Procedure: Peripheral nervous system examination; Other: Questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT02481336

A-ER-103-395

Details and patient eligibility

About

To study the risk prediction of chemotherapy-induced peripheral neuropathy (CIPN) by the clinical bioinformatics and genomic profile.

Full 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: 300 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Cancer patients receiving chemotherapy

Description:

Stage I-IV ovarian cancer receiving chemotherapy Paclitaxel/Carboplatin Stage II-IV endometrial cancer receiving chemotherapy Paclitaxel/Carboplatin Stage III \& high risk stage II colorectal cancer receiving chemotherapy with mFOLFOX 1. Questionnaires 2. Peripheral nervous system examination 3. Whole Genome Sequence

Treatment:

Procedure: Peripheral nervous system examination

Other: Questionnaires

Genetic: Whole Genome Sequence