NCT06844409Completed
Neoadjuvant FOLFOX Chemotherapy for Colon Cancer: Long-Term Chemotherapy-Induced Peripheral Neuropathy and Impact on Quality of Life
Assessment of Long-Term Chemotherapy-Induced Peripheral Neuropathy and Its Impact on Quality of Life in Colon Cancer Patients After Neoadjuvant Platinum-Containing Chemotherapy
Source: ClinicalTrials.gov · Last updated 25 Feb 2025
Brief summary (registry, in English)
The goal of this observational study was to learn about the long-term effects of neoadjuvant (pre-surgery) chemotherapy on patients with locally advanced colon cancer. The main focus was to better understand the severity of long-lasting nerve damage, known as chemotherapy-induced peripheral neuropathy (CIPN), and its impact on patients' quality of life (QoL). The key question the study aimed to answer was: What is the long-term severity of this common adverse event, and how much of an impact does it have on patients' quality of life? Participants provided detailed responses about the severity of their CIPN symptoms and the overall impact on their well-being using the FACT-GOG-Ntx questionnaire.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 54 (actual)
- First submitted
- 7 Feb 2025
- Start date
- Mar 2021
- Primary completion date
- May 2024
- Lead sponsor
- P. Herzen Moscow Oncology Research Institute
- Diseases
- Colorectal cancer
- NCT number
- NCT06844409
What you commit to
- Study type: Observational
- Participants enrolled: 54
- From Mar 2021 to the primary completion date, May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinically significant concomitant cardiac pathology (chronic heart failure NYHA class \> 1; hypertension with a risk of cardiovascular complications \> 3; history of myocardial infarction, stroke, or transient ischemic attack; presence of other decompensated cardiovascular diseases).
Other illness
- Presence of viral or infectious diseases (human immunodeficiency virus, chronic viral hepatitis, other infectious diseases in the acute phase).
- History of clinically significant central nervous system disorders.
Age
- History of other oncological diseases, except for:
- Cured non-melanoma skin cancer without known signs of recurrence or progression for \> 5 years.
- Cured carcinoma in situ without signs of recurrence or progression for \> 5 years.
Other
- Presence of distant metastases.
- ECOG performance status \> 1.
- Clinically significant peripheral polyneuropathy (\> grade 2).
- Pregnancy or lactation.
- Individual intolerance to the components of the treatment.
Who the study is looking for
- Patients with newly diagnosed, histologically confirmed, resectable colon cancer stage IIA - IIIC (cT3N0M0 \[depth of invasion \> 5 mm\], cT4a-T4bN0M0, T1-4N1-2M0).
- Age \< 75 years.
- ECOG performance status 0-1.
- Hemoglobin \> 9 g/dL.
- Absolute neutrophil count \> 1500/µL.
- Platelet count \> 100,000/µL.
- Bilirubin level \< 1.5 times the upper limit of normal.
- Creatinine clearance \> 60 mL/min (calculated using the Cockcroft-Gault formula).
- ALT and AST levels \< 2.5 times the upper limit of normal.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| P. Hertsen Moscow Oncology Research Institute Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.