Rectal Cancer CTC Trial
ConditionRectal Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Ostrava
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Tumor infiltration beyond fascia recti propria on MRI
Metastatic disease (stage IV)
Recurrent rectal cancer
Other concurrent malignancies
Trial design
Design model
Parallel
Treatments tested in this trial
Primary Surgery
Procedure/SurgeryPatients undergo radical surgical resection with TME without preceding neoadjuvant therapy
Neoadjuvant radiochemotherapy and surgery
Procedure/SurgeryNeoadjuvant treatment: long-course pelvic radiotherapy (conventional fractionation) with concurrent chemotherapy (standard fluoropyrimidine-based regimen)
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Primary SurgeryExperimental treatment 1 intervention
Group B: Neoadjuvant radiochemotherapy and surgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Circulating Tumor Cells (CTC) Dynamics - neoadjuvant treatment - shape
The detection of CTC in laboratory will be performed using fluorescence microscope. Potential CTC candidates (hotspots) were identified based on green fluorescence and subjected to operator review. The presence of CTC round shape will be observed.
Time frame
(1) before the initiation of CRT, (2) 1 week and (3) 1 month after the initiation of CRT, (4) preoperatively (1-2 weeks before surgery), (5) 1 week postoperatively, and (6) 1 month postoperatively2
Circulating Tumor Cells (CTC) Dynamics - neoadjuvant treatment - size
The detection of CTC in laboratory will be performed using fluorescence microscope. Potential CTC candidates (hotspots) were identified based on green fluorescence and subjected to operator review. The CTC size will be observed, with the border value of \> 4 μm.
Time frame
(1) before the initiation of CRT, (2) 1 week and (3) 1 month after the initiation of CRT, (4) preoperatively (1-2 weeks before surgery), (5) 1 week postoperatively, and (6) 1 month postoperatively3
Circulating Tumor Cells (CTC) Dynamics - neoadjuvant treatment - DAPI positivity
The detection of CTC in laboratory will be performed using fluorescence microscope. Potential CTC candidates (hotspots) were identified based on green fluorescence and subjected to operator review. The DAPI positivity will be observed. A DAPI-positive nucleus is a cell nucleus that has been stained with DAPI (4',6-diamidino-2-phenylindole), a fluorescent dye that binds specifically to the adenine-thymine (A-T) rich regions of double-stranded DNA.
Time frame
(1) before the initiation of CRT, (2) 1 week and (3) 1 month after the initiation of CRT, (4) preoperatively (1-2 weeks before surgery), (5) 1 week postoperatively, and (6) 1 month postoperatively4
Circulating Tumor Cells (CTC) Dynamics - neoadjuvant treatment - pancytokeratin and/or EpCAM positivity
The detection of CTC in laboratory will be performed using fluorescence microscope. Potential CTC candidates (hotspots) were identified based on green fluorescence and subjected to operator review. The presence of pancytokeratin and/or EpCAM positivity in CTCs will be observed. EpCAM positivity refers to the presence of EpCAM (Epithelial Cell Adhesion Molecule) protein on cells, which is a marker primarily expressed on epithelial cells and in many carcinomas.
Time frame
(1) before the initiation of CRT, (2) 1 week and (3) 1 month after the initiation of CRT, (4) preoperatively (1-2 weeks before surgery), (5) 1 week postoperatively, and (6) 1 month postoperativelySecondary outcomes
1
Short-term postoperative outcomes - preoperative complications
The occurrence of perioperative complications will be observed
Time frame
Within 30 days after surgery2
Short-term postoperative outcomes - 30-day morbidity
30-day morbidity will be observed
Time frame
Within 30 days after surgery3
Short-term postoperative outcomes - 30-day mortality
30-day mortality will be observed
Time frame
Within 30 days after surgery4
Local recurrence rate
Cumulative incidence of local tumor recurrence after treatment.
Time frame
Up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Ostrava
Lead sponsor
Palacky University
Collaborator
University Hospital Olomouc
Collaborator
Municipal Hospital Ostrava
Collaborator
Source ClinicalTrials.gov