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Rectal Cancer CTC Trial

NCT07194616 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-09-26

No results posted yet for this study

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-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.

Conditions

  • Rectal Cancer Patients

Interventions

PROCEDURE

Primary Surgery

Patients undergo radical surgical resection with TME without preceding neoadjuvant therapy

PROCEDURE

Neoadjuvant radiochemotherapy and surgery

Neoadjuvant treatment: long-course pelvic radiotherapy (conventional fractionation) with concurrent chemotherapy (standard fluoropyrimidine-based regimen)

Sponsors & Collaborators

  • Palacky University

    collaborator OTHER

  • University Hospital Olomouc

    collaborator OTHER

  • Municipal Hospital Ostrava

    collaborator OTHER

  • University Hospital Ostrava

    lead OTHER

Principal Investigators

  • Peter Ihnát, prof., MD, PhD, MBA · University Hospital Ostrava

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2028-03-30
Completion
2028-03-30

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07194616 on ClinicalTrials.gov