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A multicenter retrospective clinical study on the risk factors of oxaliplatin peripheral neurotoxicity and prognosis

A multicenter retrospective clinical study on the risk factors of oxaliplatin peripheral neurotoxicity and prognosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070449
Enrollment
Unknown
Registered
2023-04-12
Start date
2023-04-21
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxaliplatin-induced peripheral neuropathy

Interventions

case series:none

Sponsors

Jiangsu Province Hospital on Integration of Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. All the selected cases were in accordance with the diagnostic criteria of colorectal cancer in the ‘’Norms for the Diagnosis and Treatment of Common Malignant Tumors in China’’ of the Ministry of Health, and had been confirmed by pathology; 2. For patients with stage II-III adjuvant chemotherapy after radical resection of colorectal cancer, chemotherapy regimen was mFOLFOX6 or XELOX; 3. The predicted survival time of patients with Cartesian score above 60 is more than 6 months; 4. Patients aged 18-85 years; 5. Patients without serious damage to the heart, liver, kidney or hematopoietic system, or with abnormalities but after symptomatic treatment (such as white, platelet, liver protection, etc.) meet the inclusion requirements: (1) Hemoglobin (HGB)>=90g/L, or >=90g/L after hemoglobin infusion; (2) Absolute neutrophil count (ANC) >=1.5x10^9/L; (3) Platelet (PLT)>=75x10^9/L; (4) Liver function: ALT and AST=30g/L; (7) Serum creatinine <1.5 times the normal upper limit.

Exclusion criteria

Exclusion criteria: 1. Present peripheral neuropathy of any grade; 2. Previous treatment with neurotoxic chemotherapeutic agents, such as oxaliplatin, cisplatin, taxanes or vinca alkaloids; 3. Participate in any other clinical studies; 4. A family history of hereditary/familial peripheral neuropathy; 5. Patients with mental illness who cannot cooperate.

Design outcomes

Primary

MeasureTime frame
NCI-CTCAE4.0 neurotoxicity grading;

Secondary

MeasureTime frame
Number of chemotherapy cycles;Duration of neurotoxicity;

Countries

China

Contacts

Public ContactHuo Jiege

Jiangsu Province Hospital on Integration of Chinese and Western Medicine

hjg16688@163.com+86 15312019156

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026