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Rectal Cancer CTC Trial

RecruitingNAAges 18 Years - anyAllUniversity Hospital Ostrava
NCT07194616 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 stra

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📋 Eligibility rules (as published)
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
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What it tests

  • Primary Surgery
  • Neoadjuvant radiochemotherapy and surgery
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Where

4 sites
University Hospital Olomouc
Olomouc, Czechia
Palacky University Olomouc, Faculty of Medicine
Olomouc, Czechia
University Hospital Ostrava
Ostrava, Czechia
Municipal Hospital Ostrava - Fifejdy
Ostrava, Czechia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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