Clinical trial · Observational
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
NCT06844409CI-TRIAL-00086430NEOCIPN-COLONcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Induced Peripheral Neuropathy (CIPN) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients with colon cancer (II-III stage) who received neoadjuvant FOLFOX chemotherapy
- description
- 54 Patients with locally advanced colon cancer who received platinum-containing chemotherapy as the initial phase of their treatment, followed by surgical resection and, if indicated, adjuvant chemotherapy
Primary outcomes (2)
- measure
- Severity of long-term chemotherapy-induced peripheral neuropathy
- timeFrame
- At least 3 months after the end of platinum-containing treatment
- description
- Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-13 Version 4 (FACT/GOG-Ntx) questionnaire. The FACT/GOG-Ntx total score ranges from 0-160 with higher scores indicating better QoL and/or fewer symptoms.
- measure
- Patients' quality of life
- timeFrame
- At least 3 months after the end of platinum-containing treatment
- description
- Assessment using the the Functional Assessment of Cancer Therapy-General (FACT-G) scores within the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-13 Version 4 (FACT/GOG-Ntx) questionnaire. The FACT-G score ranges from 0-108 with higher scores indicating better QoL and/or fewer symptoms.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Presence of distant metastases. * History of other oncological diseases, except for: 1. Cured non-melanoma skin cancer without known signs of recurrence or progression for \> 5 years. 2. Cured carcinoma in situ without signs of recurrence or progression for \> 5 years. * 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). * ECOG performance status \> 1. * 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. * Clinically significant peripheral polyneuropathy (\> grade 2). * Pregnancy or lactation. * Individual intolerance to the components of the treatment.
References
Publications (5)
- BACKGROUNDTeng C; Venkatesha; Blinman PL, Vardy JL. Patterns of Patient-Reported Chemotherapy-Induced Peripheral Neuropathy in Colorectal Cancer Survivors. J Natl Compr Canc Netw. 2022 Dec;20(12):1308-1315. doi: 10.6004/jnccn.2022.7050. PMID 36509075
- BACKGROUNDLand SR, Kopec JA, Cecchini RS, Ganz PA, Wieand HS, Colangelo LH, Murphy K, Kuebler JP, Seay TE, Needles BM, Bearden JD 3rd, Colman LK, Lanier KS, Pajon ER Jr, Cella D, Smith RE, O'Connell MJ, Costantino JP, Wolmark N. Neurotoxicity from oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: NSABP C-07. J Clin Oncol. 2007 Jun 1;25(16):2205-11. doi: 10.1200/JCO.2006.08.6652. Epub 2007 Apr 30. PMID 17470850
- BACKGROUNDSoveri LM, Lamminmaki A, Hanninen UA, Karhunen M, Bono P, Osterlund P. Long-term neuropathy and quality of life in colorectal cancer patients treated with oxaliplatin containing adjuvant chemotherapy. Acta Oncol. 2019 Apr;58(4):398-406. doi: 10.1080/0284186X.2018.1556804. Epub 2019 Jan 14. PMID 30638100
- BACKGROUNDMorton D, Seymour M, Magill L, Handley K, Glasbey J, Glimelius B, Palmer A, Seligmann J, Laurberg S, Murakami K, West N, Quirke P, Gray R; FOxTROT Collaborative Group. Preoperative Chemotherapy for Operable Colon Cancer: Mature Results of an International Randomized Controlled Trial. J Clin Oncol. 2023 Mar 10;41(8):1541-1552. doi: 10.1200/JCO.22.00046. Epub 2023 Jan 19. PMID 36657089
- BACKGROUNDDavey MG, Amir AH, Ryan OK, Donnelly M, Donlon NE, Regan M, Meshkat B, Nugent E, Joyce M, Hogan AM. Evaluating the oncological safety of neoadjuvant chemotherapy in locally advanced colon carcinoma: a systematic review and meta-analysis of randomised clinical trials and propensity-matched studies. Int J Colorectal Dis. 2023 Jul 11;38(1):193. doi: 10.1007/s00384-023-04482-x. PMID 37432559