NCT06616870Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 27 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 460 (estimated)
- First submitted
- 25 Sept 2024
- Start date
- 3 Oct 2024
- Primary completion date
- 3 Oct 2029
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Diseases
- Colorectal cancer
- NCT number
- NCT06616870
What you commit to
- Study type: Observational
- Planned participants: 460
- From 3 Oct 2024 to the primary completion date, 3 Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major concomitant systemic diseases that contraindicate surgery;
Other illness
- significant cardiovascular disease (heart failure, acute myocardial infarction within the last year, active angina, cardiac arrhythmia to be treated, uncontrolled hypertension)
- systemic disease contraindicating radiotherapy
Lab values
- 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);
Other
- evidence of secondary tumour
Criteria the registry did not label
- Eligibility criteria:
- histologically confirmed diagnosis of primary resectable LARC;
- confirmed absence of distant metastases;
- ≥18 years old;
- stage of disease T3-T4 and N0-N2;
- performance status (World Health Organisation) 0-2;
- normal bone marrow, kidney and liver function;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS Coordinator of this site? Confirm its status | Aviano | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.