Rectal Cancer CTC Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Ostrava

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Tumor infiltration beyond fascia recti propria on MRI

Metastatic disease (stage IV)

Recurrent rectal cancer

Other concurrent malignancies

Trial design

Treatments tested in this trial

  • Primary Surgery
  • Neoadjuvant radiochemotherapy and surgery

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital Ostrava

Lead sponsor

Palacky University

Collaborator

University Hospital Olomouc

Collaborator

Municipal Hospital Ostrava

Collaborator