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

Enrolling by invitation

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

In brief

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.

Key facts

Study ID

NCT07346248

Run by

Istituto Clinico Humanitas

People needed

266

Starts

2025-07-21

Expected to finish

2026-07-31

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients who underwent non-operative management after neoadjuvant treatment.

Where it is running

• IRCCS Humanitas Research Hospital — Rozzano, Milan, Italy

Full record on ClinicalTrials.gov

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