Postoperative Complications After Neoadjuvant Chemoradiotherapy or Short-course Radiotherapy and Total Neoadjuvant Treatment: a Multicentric Retrospective Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chemoradiotherapy.
- Who it may be relevant to
- Registry conditions: Adult Patients With Locally Advanced Rectal Cancer Indicated to Neoadjuvant Therapy and Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Chemoradiotherapy
Comparing
Primary outcome measures
- 90 days postoperative complications [Time frame: 12 months]
- The primary endpoint of the study is the rate of 90-day postoperative complications between the study cohorts. [Time frame: 3 months]
Secondary outcome measures (8)
- 90 days severe postoperative complications between the cohorts [Time frame: 12 months]
- 90-day Comprehensive Complication Index [Time frame: 12 months]
- Treatment-related adverse reactions [Time frame: 12 months]
- Severe treatment-related adverse reactions [Time frame: 12 months]
- 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 [Time frame: 12 months]
- The rate of 90-day postoperative complications between the two cohorts in a sub-population of elderly patients [Time frame: 12 months]
- The rate of treatment-related adverse reactions between the study cohorts in a sub-population of elderly patients [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Humanitas Research Hospital — Rozzano
Identifiers
NCT: NCT07346248 · 5019