Colorectal CancerNCT07249333
Perioperative Complications After Neoadjuvant Radiotherapy for Colorectal Cancer
An observational study of Colorectal Cancer and Neoadjuvant Radiotherapy, run by Oncology Institute of Vojvodina at 1 site in Serbia.
Trial summary
Neoadjuvant radiotherapy plays an important role in the treatment of locally advanced colorectal cancer. Although radiation therapy is extremely important in reducing the tumor mass, downstaging, and therefore providing conditions for curative surgery, neoadjuvant therapy can increase the risk of perioperative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Neoadjuvant Radiotherapy, Perioperative Complication
- How many people
- 80 participants
- Where
- 1 siteSerbia
- Study dates
- 18 Jun 2024to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective radical colorectal cancer surgery in the period between 01.06.2024. and 30.06.2026. in the Oncology Institute of Vojvodina.
Who may be able to join
- Adult patients (over 18 years of age)
- Clinical Frailty Scale 2, 3 or 4 status
- Patients undergoing radical surgical treatment of colorectal cancer
Who cannot join
- Patients undergoing palliative surgical treatment of colorectal cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Serbia1 site, 1 recruiting
- Recruiting
Oncology Institute of Vojvodina
Kamenitz, Vojvodina, 21204
Nora Mihalek, MD, +381 62 343 159, noramihalek@gmail.com
About this study
Official title: Effect of Neoadjuvant Radiotherapy on the Incidence of Perioperative Complications After Radical Surgical Treatment of Colorectal Cancer
Neoadjuvant radiotherapy plays an important role in the treatment of locally advanced colorectal cancer. Although radiation therapy is extremely important in reducing the tumor mass, downstaging, and therefore providing conditions for curative surgery, neoadjuvant therapy can increase the risk of perioperative complications, which can lead to slower patient recovery, greater perioperative morbidity, prolonged hospitalization, and increased treatment costs.
The aim of the study is to determine whether there is a difference in the incidence of perioperative complications after radical colorectal cancer surgery between patients who received neoadjuvant radiotherapy and those patients who did not undergo neoadjuvant radiation.
Data is collected from the medical documentation and information system of the Oncology Institute of Vojvodina. Demographic characteristics of patients, comorbidities, length of hospital stay, length of treatment in the intensive care unit, occurrence of complications in the perioperative period, as well as data on neoadjuvant therapy are analyzed. All included patients are of similar general condition, as determined by the CFS (Clinical Frailty Scale). Intraoperative complications are graded using the ClassIntra classification of intraoperative adverse events, and the presence of postoperative adverse events are assessed and classified using the Clavien-Dindo classification of postoperative complications and the HARM (HospitAl stay, Readmission, Mortality rate) score.
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant radiotherapy group | Patients who underwent radiotherapy before the surgical treatment of colorectal cancer | |
| Control group | Patients who did not undergo radiotherapy before the surgical treatment of colorectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of particular perioperative complications (surgical site infection, urinary infection, wound dehiscence, bowel anastomosis dehiscence, ileus, reoperation)
Data collected from medical records and information system
Measured: During hospital stay (assessed up to 15 days)
Secondary outcomes (6)
ClassIntra classification of intraoperative adverse events
Maximal value: 5; Minimal value: 0 (higher score indicates worse outcome)
Measured: Perioperative/Periprocedural
Clavien-Dindo classification of postoperative adverse events
Maximal value: 5; Minimal value: 1 (higher score indicates worse outcome)
Measured: During hospital stay (assessed up to 15 days)
HARM (Hospital stay, Readmission, Mortality) scale of postoperative adverse events
Maximal value: 5; Minimal value: 0 (higher score indicates worse outcome)
Measured: During hospital stay (assessed up to 15 days)
Length of hospital stay
Number of days spent in hospital
Measured: During hospital stay (assessed up to 15 days)
Length of intensive care unit stay
Number of days spent in the intensive care unit
Measured: During hospital stay (assessed up to 15 days)
Duration of antibiotic use (Days of Therapy - DOT)
Number of days when antibiotic therapy was applied. In the case of multiple antibiotic administration, each antibiotic is counted separately and DOT is the sum of each antibiotic therapy duration in days.
Measured: During hospital stay (assessed up to 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start18 Jun 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncology Institute of Vojvodina
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nora Mihalek, Oncology Institute of Vojvodina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249333
- Sponsor's protocol ID
- 4/25/1-2086/2-2
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neoadjuvant Radiotherapy on the Incidence of Perioperative Complications After Radical Surgical Treatment of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07249333
- Acronym / sponsor ID
- 4/25/1-2086/2-2
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Oncology Institute of VojvodinaOther government
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neoadjuvant radiotherapy plays an important role in the treatment of locally advanced colorectal cancer. Although radiation therapy is extremely important in reducing the tumor mass, downstaging, and therefore providing conditions for curative surgery, neoadjuvant therapy can increase the risk of perioperative complications, which can lead to slower patient recovery, greater perioperative morbidity, prolonged hospitalization, and increased treatment costs.
The aim of the study is to determine whether there is a difference in the incidence of perioperative complications after radical colorectal cancer surgery between patients who received neoadjuvant radiotherapy and those patients who did not undergo neoadjuvant radiation.
Data is collected from the medical documentation and information system of the Oncology Institute of Vojvodina. Demographic characteristics of patients, comorbidities, length of hospital stay, length of treatment in the intensive care unit, occurrence of complications in the perioperative period, as well as data on neoadjuvant therapy are analyzed. All included patients are of similar general condition, as determined by the CFS (Clinical Frailty Scale). Intraoperative complications are graded using the ClassIntra classification of intraoperative adverse events, and the presence of postoperative adverse events are assessed and classified using the Clavien-Dindo classification of postoperative complications and the HARM (HospitAl stay, Readmission, Mortality rate) score.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant radiotherapy group | – | –Patients who underwent radiotherapy before the surgical treatment of colorectal cancer |
| Control group | – | –Patients who did not undergo radiotherapy before the surgical treatment of colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective radical colorectal cancer surgery in the period between 01.06.2024. and 30.06.2026. in the Oncology Institute of Vojvodina.
Key inclusion criteria (3 listed)
- Adult patients (over 18 years of age)
- Clinical Frailty Scale 2, 3 or 4 status
- Patients undergoing radical surgical treatment of colorectal cancer
Key exclusion criteria (1 listed)
- Patients undergoing palliative surgical treatment of colorectal cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of particular perioperative complications (surgical site infection, urinary infection, wound dehiscence, bowel anastomosis dehiscence, ileus, reoperation)
Time frame: During hospital stay (assessed up to 15 days)
Data collected from medical records and information system
6 secondary outcomes
ClassIntra classification of intraoperative adverse events
Time frame: Perioperative/Periprocedural
Clavien-Dindo classification of postoperative adverse events
Time frame: During hospital stay (assessed up to 15 days)
HARM (Hospital stay, Readmission, Mortality) scale of postoperative adverse events
Time frame: During hospital stay (assessed up to 15 days)
Length of hospital stay
Time frame: During hospital stay (assessed up to 15 days)
Length of intensive care unit stay
Time frame: During hospital stay (assessed up to 15 days)
Duration of antibiotic use (Days of Therapy - DOT)
Time frame: During hospital stay (assessed up to 15 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Neoadjuvant Radiotherapy, run by Oncology Institute of Vojvodina at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nora Mihalek, MD (+381 62 343 159, noramihalek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of particular perioperative complications (surgical site infection, urinary infection, wound dehiscence, bowel anastomosis dehiscence, ileus, reoperation) (time frame: During hospital stay (assessed up to 15 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.