Neoadjuvant chemoradiotherapy versus primary surgery with blood-based tumor cell monitoring for rectal cancer
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
We will test whether giving long-course chemoradiotherapy before surgery versus having surgery first changes circulating tumor cells in people with stage II–III rectal cancer who have no circumferential resection margin involvement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Ostrava Academic / other |
| Locations | 4 sites (Olomouc and 3 other locations) |
| Trial ID | NCT07194616 on ClinicalTrials.gov |
What this trial studies
This prospective, multicenter randomized trial compares long-course neoadjuvant chemoradiotherapy followed by surgery versus upfront total mesorectal excision in patients with stage II–III rectal cancer without MRI evidence of circumferential resection margin involvement. Participants are randomized to one of the two treatment arms and have serial blood draws at predefined time points to detect and quantify circulating tumor cells (CTCs) as a liquid biopsy biomarker. The primary focus is on the presence and dynamics of CTCs over the treatment course; secondary endpoints include perioperative morbidity and mortality, local recurrence, disease-free survival, and overall survival. The study aims to determine whether CTC monitoring provides prognostic information that could inform the use of neoadjuvant therapy in this patient group.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed stage II–III rectal adenocarcinoma within 12 cm of the anal verge, negative circumferential resection margin on staging MRI, ASA physical status I–III, and who can give informed consent.
Not a fit: Patients with metastatic (stage IV) or recurrent rectal cancer, MRI evidence of CRM involvement, other concurrent malignancies, or those unfit for surgery are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, the study could help clinicians use a simple blood test to better predict recurrence risk and decide who benefits from preoperative chemoradiotherapy.
How similar studies have performed: Observational studies have linked CTC levels and changes to recurrence risk in colorectal cancer, but randomized data comparing CTC dynamics between neoadjuvant chemoradiotherapy and upfront surgery in CRM-negative rectal cancer are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Olomouc and 3 other locations
- University Hospital Olomouc — Olomouc, Czechia (Recruiting)
- Palacky University Olomouc, Faculty of Medicine — Olomouc, Czechia (Recruiting)
- University Hospital Ostrava — Ostrava, Czechia (Recruiting)
- Municipal Hospital Ostrava - Fifejdy — Ostrava, Czechia (Recruiting)
Study contacts
- Principal investigator: Peter Ihnát, prof., MD, PhD, MBA — University Hospital Ostrava
- Study coordinator: Jiří Hynčica
- Email: jiri.hyncica@fno.cz
- Phone: 0042059737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.