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 (IGLarc)

Centro di Riferimento Oncologico - Aviano

Status: Not yet enrolling

Conditions: Rectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06616870

CRO-2023-77

Details and patient eligibility

About

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.

Enrollment: 460 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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