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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

266 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-21

Study Completion Date

2026-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Adult Patients With Locally Advanced Rectal Cancer Indicated to Neoadjuvant Therapy and Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Chemoradiotherapy

Patient received chemoradiotherapy or short course radiotherapy before surgery

Chemoradiotherapy

Intervention Type PROCEDURE

Comparing

TNT

TNT neoadjuvant treatment

Chemoradiotherapy

Intervention Type PROCEDURE

Comparing

Interventions

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Chemoradiotherapy

Comparing

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonino Spinelli, Surgery, PhD

Role: STUDY_DIRECTOR

Director Colon and Rectal Surgery -Director General Surgery Residency Program - Co-Director IBD Center Humanitas Research Hospital / Humanitas University