Evaluation of Clinical Behavior, Resectability, and Survival in Metastatic Colorectal Cancer with Fluorouracil and Capecitabine Therapy

The primary objective of the RAXO trial is to assess the **clinical behaviour** of metastatic colorectal cancer (mCRC) and evaluate overall resectability, postoperative morbidity, and outcomes following resection. This is clinically relevant as it aims to improve understanding of the disease's progression and potential for surgical intervention, which can significantly impact patient management and prognosis.

Secondary objectives include:

• To assess treatments for mCRC.
• To evaluate the efficacy of chemotherapy and targeted drugs using overall response rates (ORR), failure-free survival (FFS), progression-free survival (PFS), and overall survival (OS).
• To radiologically assess tumour density and morphology, and compare alternative radiologic response evaluations with RECIST response criteria.
• To evaluate whole blood, plasma, serum, and tumour block biomarkers, as well as DNA polymorphisms, that may predict drug effects, resectability, and clinical behaviour of the tumour in a prospective cohort.
• To conduct biomarker evaluation from diagnostic samples, primarily tumour blocks, in a retrospective data collection trial to verify diagnosis and predictive and prognostic markers in a large population-based series.
• To assess quality of life and health-related quality of life, cost-utility, QALY, and cost-benefit in a subpopulation of 100-200 patients.

The clinical trial involves participants diagnosed with **metastatic or locally advanced inoperable colorectal cancer**. The study population includes both male and female subjects aged 18 years and older. Participants are generally in a state of health that allows them to undergo first-line chemotherapy for metastatic disease. The trial does not involve a vulnerable population. The selection of participants is based on specific inclusion criteria, such as having histologically confirmed colorectal cancer and the ability to provide informed consent according to ICH/GCP and local regulations. The sponsor has not provided information regarding the total number of participants. Lifestyle factors such as diet, physical activity, or habits are not specified as part of the trial's considerations. Key inclusion criteria include the presence of metastatic disease not amenable to surgery or (chemo)radiotherapy. The trial does not involve blood sampling or direct patient contact for data collection, as data is obtained from hospital charts.

The clinical trial is designed to evaluate the clinical behavior, resectability, and survival outcomes in patients with **metastatic colorectal cancer**. This is a population-based, prospective study conducted in a randomized, double-blind, controlled manner. The trial is set to run from its recruitment start date on September 12, 2011, with an estimated end date of December 31, 2025. Participants will be involved in the study for a maximum treatment period of 60 days, during which they will receive either **fluorouracil** or **capecitabine** as part of their treatment regimen. The trial involves several key study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as histologically confirmed colorectal cancer, age of 18 years or older, and the presence of metastatic disease. Participants must provide signed informed consent according to ICH/GCP guidelines.

Following the screening, participants will undergo regular follow-up visits to monitor treatment efficacy and safety, as well as to assess the primary endpoint of clinical behavior and resectability. The end-of-study visit will conclude the participant's involvement, where final assessments will be conducted to evaluate postoperative morbidity and outcomes after resection. The expected length of participant involvement is contingent upon the treatment period, with conditions for early termination including withdrawal of consent or adverse events that compromise participant safety. The trial's primary objective is to assess the clinical behavior of metastatic colorectal cancer, with no secondary endpoints specified. The study does not involve blood sampling or direct patient contact for data collection, as data will be obtained from hospital charts. Participants are expected to adhere to the study protocol to ensure the integrity and validity of the trial results.

The clinical trial involves the administration of **Fluorouracil Accord**, a solution for injection/infusion, with a concentration of 50 mg/ml. This experimental medication is administered via **infusion**. The maximum daily dose is 2000 mg/m², with a total maximum dose of 120,000 mg/m² over a treatment period of up to 60 days. The active substance, **fluorouracil**, is a chemical compound classified under the ATC code L01BC02, indicating its role as an antineoplastic agent. The product is manufactured by Accord Healthcare B.V. and is not a pediatric formulation. Participant compliance with the dosing schedule will be monitored throughout the trial.

Additionally, the trial includes the use of **Capecitabine Orion**, a film-coated tablet containing 500 mg of the active substance **capecitabine**. This medication is administered **orally**. The maximum daily dose is 2500 mg/m², with a total maximum dose of 3,000,000 mg/m² over a treatment period of up to 60 days. Capecitabine is also a chemical compound and is classified under the ATC code L01BC06, serving as an antineoplastic agent. The product is manufactured by Orion Corporation and is not intended for pediatric use. Compliance with the oral dosing regimen will be closely monitored to ensure adherence to the study protocol.

Both medications are utilized as part of the study to evaluate clinical behavior, resectability, and survival in patients with metastatic colorectal cancer. No non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, are specified in the trial documentation. The trial aims to assess the primary objective of understanding the clinical behavior of metastatic colorectal cancer and the outcomes following resection.

The efficacy of the clinical trial will be assessed by evaluating the clinical behavior of **metastatic colorectal cancer** and determining overall resectability, postoperative morbidity, and outcomes after resection. The primary endpoint focuses on these parameters to provide a comprehensive understanding of the treatment's impact on the disease. The trial will involve patients with histologically confirmed colorectal cancer who are either scheduled to start or are currently receiving first-line chemotherapy for metastatic disease. The assessment will be conducted in a population-based prospective study format, ensuring a thorough evaluation of the clinical outcomes associated with the treatment regimen. The trial is designed to gather data on the resectability and survival of patients, contributing valuable insights into the management of metastatic colorectal cancer.