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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemoradiotherapy | Patient received chemoradiotherapy or short course radiotherapy before surgery |
| |
| TNT | TNT neoadjuvant treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemoradiotherapy | Procedure | Comparing |
|
| Measure | Description | Time Frame |
|---|---|---|
| 90 days postoperative complications | The primary endpoint of the study is the rate of 90-day postoperative complications between the study cohorts. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 90 days severe postoperative complications between the cohorts | The rate of 90-day severe postoperative complications between the study cohorts. | 12 months |
| 90-day Comprehensive Complication Index |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include all consecutive adult patients with locally advanced rectal adenocarcinoma who started a classical neoadjuvant or short-course radiotherapy or TNT treatment between January 2016 and January 2025 at the investigational centers.
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| Name | Affiliation | Role |
|---|---|---|
| Antonino Spinelli, Surgery, PhD | Director Colon and Rectal Surgery -Director General Surgery Residency Program - Co-Director IBD Center Humanitas Research Hospital / Humanitas University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Humanitas Research Hospital | Rozzano | Milan | 20089 | Italy |
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The median of the 90-day Comprehensive Complication Index (CCI) between the study cohorts.
| 12 months |
| Treatment-related adverse reactions | The rate of treatment-related adverse reactions between the study cohorts. | 12 months |
| Severe treatment-related adverse reactions | The rate of severe treatment-related adverse reactions between the study cohorts. | 12 months |
| 90-day postoperative complications between patients receiving neoadjuvant chemoradiotherapy,short-course radiotherapy, induction TNT, and consolidation TNT. | The rate of 90-day postoperative complications between patients receiving neoadjuvant chemoradiotherapy,short-course radiotherapy, induction TNT, and consolidation TNT. | 12 months |
| Treatment-related adverse reactions between patients receiving neoadjuvant chemoradiotherapy,short-course radiotherapy, induction TNT, and consolidation TNT | The rate of treatment-related adverse reactions between patients receiving neoadjuvant chemoradiotherapy,short-course radiotherapy, induction TNT, and consolidation TNT. | 12 months |
| The rate of 90-day postoperative complications between the two cohorts in a sub-population of elderly patients | 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). | 12 months |
| The rate of treatment-related adverse reactions between the study cohorts in a sub-population of elderly patients | 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). | 12 months |
| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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