Status:
RECRUITING
Rectal Cancer CTC Trial
Lead Sponsor:
University Hospital Ostrava
Collaborating Sponsors:
Palacky University
University Hospital Olomouc
Conditions:
Rectal Cancer Patients
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Colorectal cancer remains one of the most common malignancies worldwide, and rectal cancer requires a multidisciplinary treatment approach. For patients with locally advanced rectal cancer, neoadjuvan...
Eligibility Criteria
Inclusion
- Age ≥ 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07194616
Start Date
April 1 2025
End Date
March 30 2028
Last Update
September 26 2025
Active Locations (4)
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1
University Hospital Olomouc
Olomouc, Czechia, 779 00
2
Palacky University Olomouc, Faculty of Medicine
Olomouc, Czechia
3
University Hospital Ostrava
Ostrava, Czechia, 70852
4
Municipal Hospital Ostrava - Fifejdy
Ostrava, Czechia, 728 80