Clinical Research Directory
Browse clinical research sites, groups, and studies.
Rectal Cancer CTC Trial
Sponsor: University Hospital Ostrava
Summary
This prospective, multi-centre, randomised clinical trial aims to compare the effect of neoadjuvant chemoradiotherapy versus primary surgery on circulating tumor cells (CTCs) in patients with stage II-III rectal cancer without circumferential resection mar-gin involvement. CTCs are considered a promising biomarker for disease dissemination and treatment response. Patients will be randomized to either primary surgical resection with total mesorectal excision or long-course neoadjuvant chemoradiotherapy followed by surgery. Serial blood samples will be collected at predefined time points to assess the presence and dynamics of CTCs. Secondary endpoints include perioperative morbidity and mortality, local recurrence rate, disease-free survival, and overall survival. The results of this study may provide new insights into the prognostic role of CTCs and contribute to optimising treatment strategies for rectal cancer.
Official title: Impact of Neoadjuvant Chemoradiotherapy Versus Surgery Alone on Circulating Tumor Cells in Patients With Stage II-III Rectal Cancer and Negative Circumferential Resection Margin: a Multicenter Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-04-01
Completion Date
2028-03-30
Last Updated
2025-09-26
Healthy Volunteers
No
Conditions
Interventions
Primary Surgery
Patients undergo radical surgical resection with TME without preceding neoadjuvant therapy
Neoadjuvant radiochemotherapy and surgery
Neoadjuvant treatment: long-course pelvic radiotherapy (conventional fractionation) with concurrent chemotherapy (standard fluoropyrimidine-based regimen)
Locations (4)
University Hospital Olomouc
Olomouc, Czechia
Palacky University Olomouc, Faculty of Medicine
Olomouc, Czechia
University Hospital Ostrava
Ostrava, Czechia
Municipal Hospital Ostrava - Fifejdy
Ostrava, Czechia