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Clinical Trials in Italy / NCT06616870
Starting soon Observational

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

NCT06616870 · tracked via the Priya Life Science Italy tracker
Sponsor
Centro di Riferimento Oncologico - Aviano
Phase
Observational
Started
2024-10-03
Last updated
2024-09-27

Condition(s) studied

Rectal Cancer

Study summary

In locally advanced rectal cancer the pathological complete response (pCR) to neoadjuvant chemoradiation therapy (nCRT) is associated with a favourable long-term prognosis. The identification of markers predictive of response to therapy would therefore optimise treatment by allowing personalised therapy. It has been shown that the genetic profile of the patient could influence the activation of the immune system in combination with chemoradiation therapy in targeting tumour cells. In addition, genetic features of molecular pathways correlated with response to chemoradiotherapy, may in turn affect the probability of a good response to treatment in these patients, but also the occurrence of adverse events. The main objective of the study is to define the role of genetic markers related to immune system activation and other molecular pathways in predicting the complete pathological response to preoperative chemoradiation therapy in patients with locally advanced rectal cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Defining the predictive role of rare (MAF<1%) and very rare genetic variants (MAF<0.1%) in the SMAD3 and IL-17F genes, implicated in nCRT-mediated activation of the immune system on the pathological tumour response to nCRT in LARC. — up to 5 years
    Relation between rare and very rare genetic variants and pathological tumour response will be assessed with logistic regression analysis and data will be reported as odds ratio and relative confidence interval

Trial sites (1)

FacilityCityRegionStatus
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS Aviano Pordenone

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06616870 on ClinicalTrials.gov ↗ ← All trials in Italy