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Evaluating the Impact of GLP-1 Receptor Agonists With Total Neoadjuvant Therapy in Rectal Cancer

NCT07314528 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-01-02

No results posted yet for this study

Summary

The goal of this clinical trial is to see if adding a weight loss medication (GLP-1 receptor drug) to patients with an increased BMI receiving treatment for rectal cancer prior to surgery (total neoadjuvant chemoradiotherapy) improves cancer outcomes. The main questions it aims to answer is

1. Does the drug increase weight loss in rectal cancer patients with a high BMI
2. Does the drug improve response rates to chemotherapy and radiotherapy
3. Does the drug improve survival outcomes and if cancer returns

Researchers will compare this drug in one group against a group of patients receiving preoperative total neoadjuvant chemoradiotherapy without the drug

Patients will be required to

1\) take the GLP-1 receptor agonist drug during TNT or just having TNT alone as per standard hospital protocols

Body weight will be measured at three predefined time points:

1. Baseline: Prior to initiation of semaglutide or TNT
2. Pre-TNT: Start of TNT (for the intervention arm, this is 4 weeks after semaglutide initiation)
3. Post-TNT: Within 7 days following completion of TNT and prior to definitive surgery

Patients will complete their treatment and go on to have surgery as per standard methods for treating rectal cancer

Conditions

  • Rectal Cancer Patients
  • Obesity &Amp; Overweight
  • Locally Advanced Rectal Cancer (LARC)
  • Total Neoadjuvant Therapy
  • GLP-1

Interventions

DRUG

GLP-1 receptor agonist

All patients will receive standard total neoadjuvant therapy for rectal cancer as per local standards. One group will receive a GLP-1 rector agonist in addition to the standard treatment for rectal cancer

DRUG

Total neoadjuvant therapy (TNT)

Total ne-adjuvant therapy is standard treatment for locally advanced rectal cancer

Sponsors & Collaborators

  • St. James's Hospital, Ireland

    lead OTHER

Principal Investigators

  • Michael Kelly, MB BAO BCH PHD FRCSI · St. James Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-09-30
Completion
2028-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07314528 on ClinicalTrials.gov