Active — Not RecruitingNot Applicable

To Study the Individual Variants of Chemotherapy-Induced Neurotoxicity

Taiwan300 participantsStarted 2015-03

Plain-language summary

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

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Histologically confirmed epithelial ovarian cancer, endometrial cancer or adenocarcinoma of colon or rectum
✓. Pathological stage I\~IV for ovarian cancer, stage II\~IV endometrial cancer or stage III \& high risk stage II for colorectal cancer
✓. Scheduled to receive adjuvant Paclitaxel/Carboplatin for ovarian or endometrial cancer, or mFOLFOX6 for colorectal cancer
✓. Age ≥ 20 years old
✓. ECOG Performance status 0-1
✓. Adequate organ function
✓. Negative pregnancy test for women of childbearing potential only
✓. Patient willing to provide blood sample for research purposes

✕. Prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin, carboplatin, taxanes or vinca alkaloids
✕. Receiving chemotherapy within 6 months
✕. History of allergy to 5-FU or LV
✕. Pre-existing peripheral neuropathy of any grade
✕. A family history of a genetic or familial neuropathy
✕. Active uncontrolled infection
✕. 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)
✕. Poor compliance

Adverse events occurring after chemotherapy based on genomic profiling

Timeframe: up to 2 years after chemotherapy

NCT IDNCT02481336

SponsorNational Cheng-Kung University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-12-31

Who can participate

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Histologically confirmed epithelial ovarian cancer, endometrial cancer or adenocarcinoma of colon or rectum
✓. Pathological stage I\~IV for ovarian cancer, stage II\~IV endometrial cancer or stage III \& high risk stage II for colorectal cancer
✓. Scheduled to receive adjuvant Paclitaxel/Carboplatin for ovarian or endometrial cancer, or mFOLFOX6 for colorectal cancer
✓. Age ≥ 20 years old
✓. ECOG Performance status 0-1
✓. Adequate organ function
✓. Negative pregnancy test for women of childbearing potential only
✓. Patient willing to provide blood sample for research purposes

✕. Prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin, carboplatin, taxanes or vinca alkaloids
✕. Receiving chemotherapy within 6 months
✕. History of allergy to 5-FU or LV
✕. Pre-existing peripheral neuropathy of any grade
✕. A family history of a genetic or familial neuropathy
✕. Active uncontrolled infection
✕. 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)
✕. Poor compliance