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

Inclusion Criteria6

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 Criteria6

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

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)