An observational study in Adult Patients With Locally Advanced Rectal Cancer Indicated to Neoadjuvant Therapy and Surgery, sponsored by Istituto Clinico Humanitas. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Istituto Clinico Humanitas · Observational
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.
Istituto Clinico Humanitas is the lead sponsor of 275 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patient received chemoradiotherapy or short course radiotherapy before surgery
Procedure: Chemoradiotherapy
TNT neoadjuvant treatment
Procedure: Chemoradiotherapy
Comparing
90 days postoperative complications
The primary endpoint of the study is the rate of 90-day postoperative complications between the study cohorts.
Time frame: 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.
Time frame: 3 months
90 days severe postoperative complications between the cohorts
The rate of 90-day severe postoperative complications between the study cohorts.
Time frame: 12 months
90-day Comprehensive Complication Index
The median of the 90-day Comprehensive Complication Index (CCI) between the study cohorts.
Time frame: 12 months
Treatment-related adverse reactions
The rate of treatment-related adverse reactions between the study cohorts.
Time frame: 12 months
Severe treatment-related adverse reactions
The rate of severe treatment-related adverse reactions between the study cohorts.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 12 months
Plan to share: No
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Istituto Clinico Humanitas