NCT07346248

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jul 2025Jul 2026

Study Start

First participant enrolled

July 21, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 8, 2026

Last Update Submit

January 8, 2026

Conditions

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

Outcome Measures

Primary Outcomes (2)

  • 90 days postoperative complications

    The primary endpoint of the study is the rate of 90-day postoperative complications between the study cohorts.

    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.

    3 months

Secondary Outcomes (8)

  • 90 days severe postoperative complications between the cohorts

    12 months

  • 90-day Comprehensive Complication Index

    12 months

  • Treatment-related adverse reactions

    12 months

  • Severe treatment-related adverse reactions

    12 months

  • 90-day postoperative complications between patients receiving neoadjuvant chemoradiotherapy,short-course radiotherapy, induction TNT, and consolidation TNT.

    12 months

  • +3 more secondary outcomes

Study Arms (2)

Chemoradiotherapy

Patient received chemoradiotherapy or short course radiotherapy before surgery

Procedure: Chemoradiotherapy

TNT

TNT neoadjuvant treatment

Procedure: Chemoradiotherapy

Interventions

ChemoradiotherapyPROCEDURE

Comparing

ChemoradiotherapyTNT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Interventions

Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapy

Study Officials

  • Antonino Spinelli, Surgery, PhD

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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 16, 2026

Study Start

July 21, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)