Tests whether chemoradiotherapy before surgery changes tumor cells in blood for rectal cancer
Compares chemoradiotherapy before surgery with surgery alone in adults with rectal cancer.
Plain-language title generated from the registry record
Registry title: Rectal Cancer CTC Trial
Key facts
- Where
- Olomouc and Ostrava, CzechiaSee the 4 sites
Where in Czechia
- Palacky University Olomouc, Faculty of MedicineOlomouc, CzechiaTaking people
- University Hospital OlomoucOlomouc, CzechiaTaking people
- Municipal Hospital Ostrava - FifejdyOstrava, CzechiaTaking people
- University Hospital OstravaOstrava, CzechiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital Ostrava
- Trial code
- NCT07194616
- Record updated
- 26 September 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Other concurrent malignancies; Emergency surgery required; Contraindication to surgery under general anesthesia; Metastatic disease (stage IV); Recurrent rectal cancer; Tumor infiltration beyond fascia recti propria on MRI.