Phase 1b/2 Study of 5-Fluorouracil, Leucovorin, Irinotecan, Temozolomide, and Bevacizumab in MGMT Silenced, Microsatellite Stable Metastatic Colorectal Cancer

The primary objective of this study is to evaluate the efficacy and safety of a combination therapy consisting of **5-fluorouracil**, leucovorin, irinotecan, temozolomide, and bevacizumab as a first-line treatment for patients with MGMT silenced, microsatellite stable **metastatic colorectal cancer**. This is clinically relevant as it aims to improve treatment outcomes for a specific subset of colorectal cancer patients who may not respond well to standard therapies. The study does not specify any secondary objectives.

The clinical trial focuses on individuals diagnosed with **metastatic colorectal cancer**. The study population includes both male and female participants, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been disclosed. Key inclusion or exclusion criteria are not specified in the available data.

The clinical trial is designed to evaluate the efficacy and safety of a combination therapy involving **5-fluorouracil**, leucovorin, irinotecan, temozolomide, and bevacizumab for the first-line treatment of patients with **metastatic colorectal cancer** characterized by MGMT silencing and microsatellite stability. This trial is structured as a Phase 1b/2 study, employing a randomized, double-blind, and controlled methodology to ensure the reliability and validity of the results. The trial commenced on December 30, 2020, and is projected to conclude by December 30, 2025, encompassing a total duration of five years.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria are assessed. This is followed by regular follow-up visits to monitor the participants' response to the treatment and any adverse effects. The sequence of these visits is critical for collecting consistent data and ensuring participant safety. The trial will culminate in an end-of-study visit, where final assessments are conducted to evaluate the overall outcomes of the treatment regimen.

The expected length of participant involvement in the trial is contingent upon individual response to the treatment and the occurrence of any adverse events. Participants may be subject to early termination from the study if they experience significant adverse reactions, fail to comply with the study protocol, or withdraw consent. The trial's design and procedures are meticulously crafted to uphold the highest standards of clinical research, ensuring that the findings contribute valuable insights into the treatment of metastatic colorectal cancer.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In this study, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment being used alongside the experimental medication. The absence of such information suggests that the trial may focus solely on the experimental treatment, although this cannot be confirmed without further details.

Details regarding the **participant compliance monitoring** and specific **dosing schedules** are not included in the provided data. The lack of information on these aspects indicates that additional documentation or resources may be necessary to fully understand the trial's methodology and ensure adherence to the treatment protocol.

The clinical trial's efficacy assessment details are not explicitly provided in the available data. As such, specific parameters or endpoints, methods, schedules, and tools for evaluating efficacy are not mentioned. The trial is categorized under phase 7, with an estimated recruitment start date of December 30, 2020, and an estimated end date of December 30, 2025. Further information regarding the efficacy assessment would typically include the use of validated scales, laboratory tests, or patient-reported outcomes at specified timepoints, but such details are not available in the current dataset.