Neoadjuvant chemoradiotherapy versus primary surgery with blood-based tumor cell monitoring for rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter randomized trial compares long-course neoadjuvant chemoradiotherapy followed by surgery versus upfront total mesorectal excision in patients with stage II–III rectal cancer without MRI evidence of circumferential resection margin involvement. Participants are randomized to one of the two treatment arms and have serial blood draws at predefined time points to detect and quantify circulating tumor cells (CTCs) as a liquid biopsy biomarker. The primary focus is on the presence and dynamics of CTCs over the treatment course; secondary endpoints include perioperative morbidity and mortality, local recurrence, disease-free survival, and overall survival. The study aims to determine whether CTC monitoring provides prognostic information that could inform the use of neoadjuvant therapy in this patient group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• University Hospital Olomouc
  Olomouc, Czechia Recruiting
• Palacky University Olomouc, Faculty of Medicine
  Olomouc, Czechia Recruiting
• University Hospital Ostrava
  Ostrava, Czechia Recruiting
• Municipal Hospital Ostrava - Fifejdy
  Ostrava, Czechia Recruiting

Study contacts

• Principal investigator: Peter Ihnát, prof., MD, PhD, MBA — University Hospital Ostrava
• Study coordinator: Jiří Hynčica
• Email: jiri.hyncica@fno.cz
• Phone: 0042059737

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.