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

ConditionRectal Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro di Riferimento Oncologico - Aviano

About this trial

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 criteria

Qualifiers

histologically confirmed diagnosis of primary resectable LARC;

confirmed absence of distant metastases;

≥18 years old;

stage of disease T3-T4 and N0-N2;

Disqualifiers

evidence of secondary tumour

inadequate liver function (bilirubin >1.5 times the normal range, ALT and AST >2 times the normal range);

inadequate renal function (creatinine >1.5 times the upper limit of normal range);

Major concomitant systemic diseases that contraindicate surgery;

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed