Perioperative complications after neoadjuvant radiotherapy for colorectal cancer
Effect of Neoadjuvant Radiotherapy on the Incidence of Perioperative Complications After Radical Surgical Treatment of Colorectal Cancer
This study will see if adults with colorectal cancer who receive preoperative (neoadjuvant) radiotherapy have different rates of perioperative complications after radical surgery compared with those who do not.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oncology Institute of Vojvodina Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Kamenitz, Vojvodina) |
| Trial ID | NCT07249333 on ClinicalTrials.gov |
What this trial studies
This retrospective observational study uses medical records from the Oncology Institute of Vojvodina to compare patients who received neoadjuvant radiotherapy with those who did not. Researchers will extract demographic data, comorbidities, Clinical Frailty Scale, length of hospital and intensive care stay, and perioperative complications from the institute's information system. The primary analysis compares the incidence and severity of perioperative complications following radical colorectal cancer surgery between the two groups, with subgroup analyses by frailty and comorbidity burden. Adults undergoing curative-intent colorectal resection with Clinical Frailty Scale 2–4 are included while palliative surgeries are excluded.
Who should consider this trial
Good fit: Adults over 18 years old with colorectal cancer, Clinical Frailty Scale 2–4, undergoing radical (curative-intent) colorectal surgery at the Oncology Institute of Vojvodina.
Not a fit: Patients undergoing palliative colorectal surgery, children, or those with Clinical Frailty Scale outside the 2–4 range would not be included and are unlikely to benefit from these results.
Why it matters
Potential benefit: If successful, the results could help clinicians and patients weigh the benefits of tumor downstaging against the risk of increased perioperative complications and improve perioperative planning.
How similar studies have performed: Previous studies have reported mixed results—some have found increased perioperative morbidity after neoadjuvant radiotherapy (particularly when combined with chemotherapy), while others showed little or no difference, so this question remains unsettled.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (over 18 years of age) * Clinical Frailty Scale 2, 3 or 4 status * Patients undergoing radical surgical treatment of colorectal cancer Exclusion Criteria: * Patients undergoing palliative surgical treatment of colorectal cancer
Where this trial is running
Kamenitz, Vojvodina
- Oncology Institute of Vojvodina — Kamenitz, Vojvodina, Serbia (Recruiting)
Study contacts
- Study coordinator: Nora Mihalek, MD
- Email: noramihalek@gmail.com
- Phone: +381 62 343 159
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.