Adult Patients With Locally Advanced Rectal Cancer Indicated to Neoadjuvant Therapy and SurgeryPOCATNCT07346248
Postoperative Complications After Neoadjuvant Chemoradiotherapy or Short-course Radiotherapy and Total Neoadjuvant Treatment: a Multicentric Retrospective Cohort Study
An observational study of Adult Patients With Locally Advanced Rectal Cancer Indicated to Neoadjuvant Therapy and Surgery, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Patients With Locally Advanced Rectal Cancer Indicated to Neoadjuvant Therapy and Surgery
- What is being tested?
- Chemoradiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 266 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jul 2025to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who underwent non-operative management after neoadjuvant treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Adult Patients With Locally Advanced Rectal Cancer Indicated to Neoadjuvant Therapy and Surgery
- Being tested
- Chemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemoradiotherapyProcedure or surgery
Comparing
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiotherapy | Patient received chemoradiotherapy or short course radiotherapy before surgery Receives: Procedure: Chemoradiotherapy | |
| TNT | TNT neoadjuvant treatment Receives: Procedure: Chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
90 days postoperative complications
The primary endpoint of the study is the rate of 90-day postoperative complications between the study cohorts.
Measured: 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.
Measured: 3 months
Secondary outcomes (8)
90 days severe postoperative complications between the cohorts
The rate of 90-day severe postoperative complications between the study cohorts.
Measured: 12 months
90-day Comprehensive Complication Index
The median of the 90-day Comprehensive Complication Index (CCI) between the study cohorts.
Measured: 12 months
Treatment-related adverse reactions
The rate of treatment-related adverse reactions between the study cohorts.
Measured: 12 months
Severe treatment-related adverse reactions
The rate of severe treatment-related adverse reactions between the study cohorts.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start21 Jul 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients With Locally Advanced Rectal Cancer Indicated to Neoadjuvant Therapy and SurgeryStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonino Spinelli, Surgery, PhD, Study director, Director Colon and Rectal Surgery -Director General Surgery Residency Program - Co-Director IBD Center Humanitas Research Hospital / Humanitas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346248
- Sponsor's protocol ID
- 5019
- Acronym
- POCAT
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Complications After Neoadjuvant Chemoradiotherapy or Short-course Radiotherapy and Total Neoadjuvant Treatment: a Multicentric Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07346248
- Acronym / sponsor ID
- POCAT / 5019
- Conditions
- Adult Patients With Locally Advanced Rectal Cancer Indicated to Neoadjuvant Therapy and Surgery
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemoradiotherapy | – | Procedure: ChemoradiotherapyPatient received chemoradiotherapy or short course radiotherapy before surgery |
| TNT | – | Procedure: ChemoradiotherapyTNT neoadjuvant treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who underwent non-operative management after neoadjuvant treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemoradiotherapyComparing | Procedure or surgery | Chemoradiotherapy, TNT |
Primary outcome
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.
The primary endpoint of the study is the rate of 90-day postoperative complications between the study cohorts.
Time frame: 3 months
The primary endpoint of the study is the rate of 90-day postoperative complications between the study cohorts.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonino Spinelli, Surgery, PhD study director
Director Colon and Rectal Surgery -Director General Surgery Residency Program - Co-Director IBD Center Humanitas Research Hospital / Humanitas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Patients With Locally Advanced Rectal Cancer Indicated to Neoadjuvant Therapy and Surgery, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90 days postoperative complications (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.