Adult Patients With Locally Advanced Rectal Cancer Indicated to Neoadjuvant Therapy and Surgery
Conditions
Brief summary
The primary objective of the study is to compare the rate of postoperative complications between rectal cancer patients undergoing standard neoadjuvant chemoradiotherapy or short- course radiotherapy and patients receiving TNT. The secondary objectives of the study include the evaluation of treatment-related adverse reactions and postoperative complications in elderly patients receiving the treatments and the comparison of treatment-related adverse reactions and postoperative complications in patients receiving induction versus consolidation TNT.
Interventions
PROCEDUREChemoradiotherapy
Comparing
Sponsors
Istituto Clinico Humanitas
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with locally advanced (T2N+, T3N+, T4N0, or T4N+) rectal adenocarcinoma who underwent neoadjuvant chemoradiotherapy or short-course radiotherapy or TNT and surgery between January 2016 and January 2025; * Patients who underwent restorative or non-restorative surgery; * Patients undergoing open, laparoscopic, or robotic intervention.
Exclusion criteria
* Patients who underwent non-operative management after neoadjuvant treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90 days postoperative complications | 12 months | The primary endpoint of the study is the rate of 90-day postoperative complications between the study cohorts. |
| The primary endpoint of the study is the rate of 90-day postoperative complications between the study cohorts. | 3 months | The primary endpoint of the study is the rate of 90-day postoperative complications between the study cohorts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-related adverse reactions | 12 months | The rate of treatment-related adverse reactions between the study cohorts. |
| Severe treatment-related adverse reactions | 12 months | The rate of severe treatment-related adverse reactions between the study cohorts. |
| 90-day postoperative complications between patients receiving neoadjuvant chemoradiotherapy,short-course radiotherapy, induction TNT, and consolidation TNT. | 12 months | The rate of 90-day postoperative complications between patients receiving neoadjuvant chemoradiotherapy,short-course radiotherapy, induction TNT, and consolidation TNT. |
| 90 days severe postoperative complications between the cohorts | 12 months | The rate of 90-day severe postoperative complications between the study cohorts. |
| The rate of 90-day postoperative complications between the two cohorts in a sub-population of elderly patients | 12 months | The rate of 90-day postoperative complications between the two cohorts in a sub-population of elderly patients (≥ 70 years old at the time of diagnosis). |
| The rate of treatment-related adverse reactions between the study cohorts in a sub-population of elderly patients | 12 months | The rate of treatment-related adverse reactions between the study cohorts in a sub-population of elderly patients (≥ 70 years old at the time of diagnosis). |
| Treatment-related adverse reactions between patients receiving neoadjuvant chemoradiotherapy,short-course radiotherapy, induction TNT, and consolidation TNT | 12 months | The rate of treatment-related adverse reactions between patients receiving neoadjuvant chemoradiotherapy,short-course radiotherapy, induction TNT, and consolidation TNT. |
| 90-day Comprehensive Complication Index | 12 months | The median of the 90-day Comprehensive Complication Index (CCI) between the study cohorts. |
Countries
Italy
Outcome results
None listed