Study of the Predictive and Prognostic Role of Pharmacogenetic and Radiogenic Variants on the Response to Neoadjuvant Chemoradiation Therapy in Patients With Locally Advanced Rectal Cancer

Launched by CENTRO DI RIFERIMENTO ONCOLOGICO - AVIANO · Sep 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how certain genetic factors in patients with locally advanced rectal cancer might help predict how well they will respond to a specific treatment called neoadjuvant chemoradiation therapy (nCRT). This therapy combines chemotherapy and radiation before surgery to shrink tumors. The researchers want to find out if understanding these genetic markers can help doctors tailor treatments to individual patients, potentially leading to better outcomes and fewer side effects.

To participate in this study, you need to be at least 18 years old and have a confirmed diagnosis of rectal cancer that can be surgically removed. You should also have no signs of cancer spreading to other parts of your body and meet specific health criteria, like having normal kidney and liver function. The trial is currently not recruiting participants, but it aims to help improve treatment options for people with this type of cancer in the future. If you join, you can expect to provide samples for genetic testing and receive close monitoring during your treatment.

Gender

ALL

Eligibility criteria

• Eligibility criteria:
• • 1. histologically confirmed diagnosis of primary resectable LARC;
• • 2. confirmed absence of distant metastases;
• • 3. ≥18 years old;
• • 4. stage of disease T3-T4 and N0-N2;
• • 5. performance status (World Health Organisation) 0-2;
• • 6. normal bone marrow, kidney and liver function;
• Exclusion Criteria:
• • 1. evidence of secondary tumour
• • 2. inadequate liver function (bilirubin \>1.5 times the normal range, ALT and AST \>2 times the normal range);
• • 3. inadequate renal function (creatinine \>1.5 times the upper limit of normal range);
• • 4. Major concomitant systemic diseases that contraindicate surgery;
• • 5. significant cardiovascular disease (heart failure, acute myocardial infarction within the last year, active angina, cardiac arrhythmia to be treated, uncontrolled hypertension)
• • 6. systemic disease contraindicating radiotherapy