NCT07194616Recruiting
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
Source: ClinicalTrials.gov · Last updated 26 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 11 Sept 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 30 Mar 2028
- Lead sponsor
- University Hospital Ostrava
- Diseases
- Colorectal cancer
- NCT number
- NCT07194616
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Apr 2025 to the primary completion date, 30 Mar 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other concurrent malignancies
- Emergency surgery required
- Contraindication to surgery under general anesthesia
Other illness
- Metastatic disease (stage IV)
- Recurrent rectal cancer
Other
- Tumor infiltration beyond fascia recti propria on MRI
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Recruiting |
| Palacky University Olomouc, Faculty of Medicine Coordinator of this site? Confirm its status | Olomouc | Czechia | Recruiting |
| Municipal Hospital Ostrava - Fifejdy Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| University Hospital Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.