Actively Recruiting
Rectal Cancer CTC Trial
Led by University Hospital Ostrava · Updated on 2025-09-26
120
Participants Needed
4
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
University Hospital Ostrava
Lead Sponsor
P
Palacky University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rectal Cancer CTC Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63; 18 years
- Histologically confirmed rectal adenocarcinoma within 12 cm from anal verge
- Stage II (cT3-4 N0 M0) or stage III (cT1-4 N1-2, M0)
- Negative circumferential resection margin on staging MRI
- ASA physical status I-III
- Signed informed consent
You will not qualify if you...
- Tumor infiltration beyond fascia recti propria on MRI
- Metastatic disease (stage IV)
- Recurrent rectal cancer
- Other concurrent malignancies
- Emergency surgery required
- Contraindication to surgery under general anesthesia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
University Hospital Olomouc
Olomouc, Czechia, 779 00
Actively Recruiting
2
Palacky University Olomouc, Faculty of Medicine
Olomouc, Czechia
Actively Recruiting
3
University Hospital Ostrava
Ostrava, Czechia, 70852
Actively Recruiting
4
Municipal Hospital Ostrava - Fifejdy
Ostrava, Czechia, 728 80
Actively Recruiting
Research Team
J
Jiří Hynčica
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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