Evaluation of Neoadjuvant Chemotherapy with Capecitabine and Oxaliplatin in Locally Advanced Colon Cancer: A Comparative Study with Standard Treatment

The primary objective of this study is to evaluate the effect of **neoadjuvant chemotherapy** on disease-free survival in patients with locally advanced **colon cancer**. This is clinically relevant as improving disease-free survival can potentially lead to better long-term outcomes and quality of life for patients with this condition. The study compares neoadjuvant chemotherapy to standard treatment, aiming to determine if the former offers a significant advantage in managing locally advanced colon cancer.

The clinical trial focuses on **colon cancer** and involves a study population comprising both male and female participants. The age range of the participants is categorized as adults, specifically those aged 18 years and older. The trial includes individuals with a histologically verified diagnosis of locally advanced T3 or T4 colon cancer, as assessed by CT scan. Participants are required to have a performance status (PS) of 0-2, indicating they are ambulatory and capable of self-care. The trial population was selected based on specific hematological and biochemical criteria, including adequate levels of ANC and thrombocytes, as well as controlled bilirubinemia and ALAT levels. Fertile women participating in the study must present a negative pregnancy test and adhere to secure contraceptive measures during and for three months following treatment. The trial also involves a vulnerable population, although the specific nature of this vulnerability is not detailed. The sponsor has not provided information regarding the total number of participants in the study.

The clinical trial is designed to evaluate the efficacy of **neoadjuvant chemotherapy** in patients with locally advanced **colon cancer**. This is a phase III, randomized, double-blind, controlled trial aimed at assessing the impact of the treatment on two-year disease-free survival. The trial involves the administration of **capecitabine** and **oxaliplatin** as the investigational medicinal products. Participants will be randomly assigned to receive either the neoadjuvant chemotherapy regimen or the standard treatment. The trial is expected to conclude by December 31, 2026, with recruitment having commenced on September 2, 2013.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as histologically verified locally advanced T3 or T4 colon cancer, age of 18 years or older, and specific hematology and biochemistry parameters. Following the screening, participants will attend regular follow-up visits to monitor treatment response and adverse events. The end-of-study visit will occur at the conclusion of the treatment period or upon early termination from the study.

The expected duration of participant involvement is up to 24 months, corresponding to the maximum treatment period. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or failure to comply with study protocols. The trial's primary endpoint is the two-year disease-free survival, with no secondary endpoints specified. The trial is not categorized as low intervention, and it is conducted under rigorous scientific and ethical standards to ensure the validity and reliability of the results.

The clinical trial involves the administration of **CAPECITABINE**, an experimental medication used in the treatment of locally advanced colon cancer. **CAPECITABINE** is provided in the form of a **COATED TABLET** and is administered **orally**. The dosage is calculated based on body surface area, with a maximum daily dose of 2000 mg/m². The total maximum dose over the treatment period is 224,000 mg/m². The treatment duration is set for a maximum of 24 weeks. **CAPECITABINE** is a chemical substance and is classified under chemotherapy agents. Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the prescribed regimen.

Another experimental medication used in this trial is **OXALIPLATIN**, which is administered as a **CONCENTRATE FOR SOLUTION FOR INFUSION**. The route of administration is **intracavernous use**. The dosage is also based on body surface area, with a maximum daily dose of 130 mg/m² and a total maximum dose of 1040 mg/m² over the treatment period. Similar to **CAPECITABINE**, the treatment period for **OXALIPLATIN** is up to 24 weeks. **OXALIPLATIN** is a chemical substance and functions as an antineoplastic agent. Compliance with the administration schedule is closely monitored to ensure the integrity of the trial results.

No non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, are specified in this trial. The focus is on evaluating the efficacy of the neoadjuvant chemotherapy regimen consisting of **CAPECITABINE** and **OXALIPLATIN** in improving disease-free survival in patients with locally advanced colon cancer.

Efficacy in the clinical trial titled "Neoadjuvant chemotherapy versus standard treatment in patients with locally advanced colon cancer (NeoCol)" will be assessed primarily through the endpoint of two-year **disease-free survival**. This parameter will be used to evaluate the effect of neoadjuvant chemotherapy in patients with locally advanced colon cancer. The trial aims to determine the impact of the treatment regimen on extending the period during which patients remain free from disease recurrence. The assessment of disease-free survival will be conducted over a specified period, with the primary endpoint being measured at the two-year mark following treatment initiation. The trial is designed as a phase III study, focusing on the comparative efficacy of neoadjuvant chemotherapy against standard treatment protocols. The efficacy assessments will be based on clinical evaluations and follow-up data collected throughout the trial duration, ensuring a comprehensive analysis of the treatment's impact on disease progression.