Systemic Neoadjuvant and Adjuvant Control by Precision Medicine in Rectal Cancer
Status:
Not yet recruiting
Trial end date:
2031-12-31
Target enrollment:
Participant gender:
Summary
Rectal cancer represents the most complex area of multidisciplinary treatment in bowel
surgery. In 2017, there were 1221 new rectal cancers in Finland. The prognosis of colorectal
cancer (CRC) patients these days is almost exclusively driven by the occurrence of the
metastatic form of the disease.
The treatment of rectal cancer often includes a long delay between diagnosis and the
initiation of systemic chemotherapy, increasing risk for systemic metastases for those at
high risk. On the other hand, the waiting time during pretreatment before surgery enables
comprehensive systematic characterization of the primary tumor status before the decisions on
adjuvant chemotherapy, opening a window to the use of precision in decision-making.
In this randomized controlled treatment trial, outcomes of novel precision methods to select
right rectal cancer patients for treatment that they need will be compared to conventional
treatment. The study aims to reduce over-treatment of those that most likely do not benefit
from additional treatments. With the overall aim to reduce metastatic form of the disease,
patients with high-risk features will be randomized to a treatment strategy with early
systemic control by chemotherapy followed by circulating tumor DNA (ctDNA) and
organoid-guided adjuvant therapy, or to conventional treatment strategy. Both
state-of-the-art laboratory practice and routine diagnostic clinical pipelines are introduced
to bring future diagnostic models of minimal residual disease and chemoresistance closer to
current practice. The outcomes will reveal the clinical benefit of such strategy by
recurrence-free survival at highest level of evidence, and produce important clinical outcome
data on the application of ctDNA in everyday cancer treatment practice. The translational
data on the use of ctDNA organoids to inform treatment decision and regimen selection will
build knowledge of the use of such biomarkers as tools for clinical practice and clinical
research. The results will be scalable worldwide in the practice of rectal cancer treatment.