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

I

Istituto Clinico Humanitas

Status

Invitation-only

Conditions

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

Treatments

Procedure: Chemoradiotherapy

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

266 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

266 participants in 2 patient groups

Chemoradiotherapy
Description:
Patient received chemoradiotherapy or short course radiotherapy before surgery
Treatment:
Procedure: Chemoradiotherapy
TNT
Description:
TNT neoadjuvant treatment
Treatment:
Procedure: Chemoradiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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