Rectal Cancer CTC Trial

NCT ID: NCT07194616

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2028-03-30

Brief 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.

Detailed Description

Colorectal cancer remains one of the most common malignancies worldwide, and rectal cancer requires a multidisciplinary treatment approach. For patients with locally advanced rectal cancer, neoadjuvant chemoradiotherapy (nCRT) followed by surgical resection has been widely used to reduce the risk of local recurrence. However, the indication for nCRT in patients without circumferential resection margin (CRM) involvement remains controversial. While some studies have suggested benefits of nCRT, others have shown comparable oncological outcomes with primary surgery when high-quality total mesorectal excision (TME) is performed.

Circulating tumor cells (CTCs) are malignant cells detectable in peripheral blood that have been associated with metastatic potential and poor prognosis in various cancers, including colorectal cancer. Monitoring the presence and dynamics of CTCs offers a minimally invasive "liquid biopsy" approach that may provide prognostic information and reflect treatment efficacy. Existing evidence suggests that changes in CTC levels after surgery or systemic therapy may correlate with recurrence risk and survival, but relevant data in rectal cancer patients undergoing multimodal treatment are limited.

This prospective, multi-centre, randomised clinical trial will enrol patients with stage II-III rectal cancer without evidence of CRM involvement on staging magnetic resonance imaging (MRI). Eligible patients will be randomized into two study arms:

1. Primary surgery arm: radical surgical resection with total mesorectal excision (TME).

2. Neoadjuvant therapy arm: long-course neoadjuvant chemoradiotherapy fol-lowed by delayed surgical resection.

Peripheral blood samples will be collected at predefined time points in both groups to determine the presence and quantity of CTCs. The primary objective is to compare the effect of neoadjuvant chemoradiotherapy versus surgery alone on CTC dynamics.

Secondary objectives include:

• Evaluation of short-term surgical outcomes (perioperative complications, 30-day morbidity and mortality).
• Assessment of long-term oncological outcomes (local recurrence, disease-free survival, and overall survival at 3 and 5 years).

By integrating CTC monitoring into a modern randomized clinical trial design, this study aims to clarify the prognostic value of CTCs in rectal cancer and determine whether specific treatment strategies are associated with more favourable biological and clinical outcomes. The findings may contribute to more individualised treatment planning and potentially reduce the risk of recurrence and mortality in rectal cancer patients.

Conditions

Rectal Cancer Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Primary Surgery

Procedure: rectal resection with TME (Total Mesorectal Excision)

Group Type: EXPERIMENTAL

Primary Surgery

Intervention Type: PROCEDURE

Patients undergo radical surgical resection with TME without preceding neoadjuvant therapy

Neoadjuvant radiochemotherapy and surgery

Procedure: rectal resection with TME performed 6-10 weeks after completion of chemoradiotherapy.

Group Type: EXPERIMENTAL

Neoadjuvant radiochemotherapy and surgery

Intervention Type: PROCEDURE

Neoadjuvant treatment: long-course pelvic radiotherapy (conventional fractionation) with concurrent chemotherapy (standard fluoropyrimidine-based regimen)

Interventions

Primary Surgery

Patients undergo radical surgical resection with TME without preceding neoadjuvant therapy

Intervention Type: PROCEDURE

Neoadjuvant radiochemotherapy and surgery

Neoadjuvant treatment: long-course pelvic radiotherapy (conventional fractionation) with concurrent chemotherapy (standard fluoropyrimidine-based regimen)

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Palacky University

OTHER

Sponsor Role: collaborator

University Hospital Olomouc

OTHER

Sponsor Role: collaborator

Municipal Hospital Ostrava

OTHER

Sponsor Role: collaborator

University Hospital Ostrava

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Ihnát, prof., MD, PhD, MBA

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ostrava

Locations

University Hospital Olomouc

Olomouc, , Czechia

Site Status: RECRUITING

Palacky University Olomouc, Faculty of Medicine

Olomouc, , Czechia

Site Status: RECRUITING

University Hospital Ostrava

Ostrava, , Czechia

Site Status: RECRUITING

Municipal Hospital Ostrava - Fifejdy

Ostrava, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Jiří Hynčica

Role: CONTACT

jiri.hyncica@fno.cz

0042059737 ext. 2587

Facility Contacts

Petr Špička, MD, PhD

Role: primary

petr.spicka@fnol.cz

00420588442415

Josef Srovnal, M.D., Ph.D., Assist. Prof.

Role: primary

josef.srovnal@upol.cz

00420585632137

Peter Ihnát, prof., MD, PhD, MBA

Role: primary

peter.ihnat@fno.cz

0042059737 ext. 5701

Branislav Šnajder, MD

Role: primary

chirurgie@mnof.cz

00420596192480

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Other Identifiers

RECTA-CTC

Identifier Type: -

Identifier Source: org_study_id