RecruitingNot ApplicableNCT07194616

Rectal Cancer CTC Trial

Impact of Neoadjuvant Chemoradiotherapy Versus Surgery Alone on Circulating Tumor Cells in Patients With Stage II-III Rectal Cancer and Negative Circumferential Resection Margin: a Multicenter Randomized Clinical Trial

Sponsor

University Hospital Ostrava

Enrollment

120 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Rectal Cancer Patients

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether measuring circulating tumor cells (CTCs) — cancer cells that have broken off from the tumor and are floating in the bloodstream — can help predict outcomes and guide treatment decisions in people with rectal cancer who are eligible for surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with rectal adenocarcinoma (a type of rectal cancer) located within 12 cm of the anal opening - Your cancer is stage II (T3-4, no lymph node involvement) or stage III (lymph nodes involved), but has not spread to distant organs - MRI imaging shows the surgical margin is clear (negative circumferential resection margin) - Your general fitness is adequate for surgery (ASA I–III) **You may NOT be eligible if...** - Your cancer has spread to other organs (stage IV) - Your cancer is recurrent (has come back after prior treatment) - You have another concurrent cancer - You need emergency surgery - You cannot safely undergo general anesthesia - Imaging shows your tumor has grown beyond the rectal fascia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPrimary Surgery

Patients undergo radical surgical resection with TME without preceding neoadjuvant therapy

PROCEDURENeoadjuvant radiochemotherapy and surgery

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