Modified FOLFOXIRI Plus Target Therapy as a First Line Treatment for Advanced Colorectal Cancer a Prospective Phase Two Study

Launched by AL-AZHAR UNIVERSITY · Aug 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called modified FOLFOXIRI for patients with advanced colorectal cancer, specifically those whose cancer has spread to other parts of the body. The goal is to see if this modified treatment can be effective while reducing some of the side effects that can come from the standard FOLFOXIRI regimen, which is known to be quite tough on the body. Researchers will look at how well the treatment works, how safe it is, and whether it can help patients live longer without their cancer getting worse.

To participate in this study, you need to have been diagnosed with metastatic colorectal cancer that cannot be surgically removed. Other key criteria include having a good performance status (which means you can carry out daily activities with little difficulty), and your lab results and heart function need to meet certain standards. If you join, you can expect close monitoring during the treatment to manage any side effects and ensure your safety. This trial is currently recruiting participants of all genders aged between 65 and 74, and it aims to offer a potentially safer and effective option for those facing this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed unrespectable or metastatic colorectal cancer with or without primary tumor in situ.
• • Patients were required to have measurable disease according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) (Eisenhauer EA,2009)
• • ECOG PS 0-1 better to exclude PS II as this protocol is known to be toxic
• • Adequate baseline hematology and clinical chemistry labs
• • Adequate cardiac function
• Exclusion Criteria:
• • Double Malignancy
• • DPYD mutant patients
• • Peripheral neuropathy grade 3 or higher patient due to other comorbidities
• • Inflammatory bowel syndrome or any other chronic GIT disease
• • Prior exposure to chemotherapy treatment for colorectal cancer in the metastatic setting
• • Patients who have contraindications for one or more of the study protocol drugs