Neoadjuvant FOLFOX Chemotherapy for Colon Cancer: Long-Term Chemotherapy-Induced Peripheral Neuropathy and Impact on Quality of Life

NCT06844409 | Completed

• 1 other identifier: 72-2021
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Keywords

chemotherapy-induced peripheral neuropathy; oxaliplatin; quality of life; neoadjuvant chemotherapy; colon cancer

Outcome Measures

Primary Outcomes (2)

• Severity of long-term chemotherapy-induced peripheral neuropathy

  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.

  At least 3 months after the end of platinum-containing treatment

• Patients' quality of life

  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.

  At least 3 months after the end of platinum-containing treatment

Secondary Outcomes (3)

• Severity of acute chemotherapy-induced peripheral neuropathy

  Through platinum-containing chemotherapy treatment completion, an average of 3,5 months

• Correlation between risk factors and severity of chemotherapy-induced peripheral neuropathy

  Through study completion, an average of 2 years

• Correlation between severity of long-term chemotherapy induced neuropathy and quality of life

  At least 3 months after the end of platinum-containing treatment

Study Arms (1)

Patients with colon cancer (II-III stage) who received neoadjuvant FOLFOX chemotherapy

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study includes patients who were treated for locally advanced colon cancer in P. Hertsen Oncology Clinical Research Institute in Moscow, Russian Federation

You may qualify if:

• 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.

You may not qualify if:

• Presence of distant metastases.
• 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.
• 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.

Sponsors & Collaborators

• P. Herzen Moscow Oncology Research Institute: lead
• Jiaxing University: collaborator

Study Sites (1)

P. Hertsen Moscow Oncology Research Institute

Moscow, Moscow, 125284, Russia

Location

Related Publications (5)

• Teng 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 BACKGROUND

• Land 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 BACKGROUND

• Soveri 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 BACKGROUND

• Morton 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 BACKGROUND

• Davey 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 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 25, 2025
• Study Start: March 19, 2021
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement

Locations

RU (1)