Rectal Cancer CTC Trial

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

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

Conditions2

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