Postoperative Complications After Neoadjuvant Chemoradiotherapy or Short-course Radiotherapy and Total Neoadjuvant Treatment: a Multicentric Retrospective Cohort Study (POCAT)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Adult Patients With Locally Advanced Rectal Cancer Indicated to Neoadjuvant Therapy and Surgery
• Intervention / Treatment: Procedure: Chemoradiotherapy

• Study Type: Observational
• Enrollment (Estimated): 266

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Irccs Humanitas Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chemoradiotherapy; Patient received chemoradiotherapy or short course radiotherapy before surgery	Procedure: Chemoradiotherapy; Comparing
TNT; TNT neoadjuvant treatment	Procedure: Chemoradiotherapy; Comparing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Investigators: Study Director: Antonino Spinelli, Surgery, PhD, Director Colon and Rectal Surgery -Director General Surgery Residency Program - Co-Director IBD Center Humanitas Research Hospital / Humanitas University

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Drug Therapy; Radiotherapy; Combined Modality Therapy; Chemoradiotherapy
• Other Study ID Numbers: 5019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No