Rectal Cancer CTC Trial

Recruiting now · Not applicable

Conditions studied: Rectal Cancer Patients

In brief

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.

Key facts

Study ID

NCT07194616

Run by

University Hospital Ostrava

People needed

120

Starts

2025-04-01

Expected to finish

2028-03-30

Last updated by the study team

2025-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Hospital Olomouc — Olomouc, Czechia (enrolling)
• Palacky University Olomouc, Faculty of Medicine — Olomouc, Czechia (enrolling)
• University Hospital Ostrava — Ostrava, Czechia (enrolling)
• Municipal Hospital Ostrava - Fifejdy — Ostrava, Czechia (enrolling)

Full record on ClinicalTrials.gov

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