Pre-operative 3-DCRT vs IMRT for Locally Advanced Rectal Cancer (TRI-LARC)

Randomised Phase II Study of Pre-operative 3-D Conformal Radiotherapy (3-DCRT) Versus Intensity Modulated Radiotherapy (IMRT) for Locally Advanced Rectal Cancer

The study aims to compare the incidence of acute grade 2 GI toxicity in the Control 3-D Conformal Radiotherapy compared to the Intensity Modulated Radiotherapy (IMRT) arm for locally advanced rectal cancer.

Study Overview

• Status: Terminated
• Conditions: Locally Advanced Rectal Cancer
• Intervention / Treatment: Radiation: IMRT

Detailed Description

Pre-operative radiotherapy (RT) or chemo-radiotherapy (CRT) is internationally accepted as standard practice in the management of locally advanced rectal cancer.

Multiple randomised trials have proved pre-operative CRT and RT, compared to surgery alone, reduce local recurrence, even prior to optimal surgery, and may improve survival for T3 circumferential resection margin (CRM) negative patients.

This study aims to determine if 3-DCRT or IMRT result in lower incidence of grade 2 GI toxicities.

Acute toxicities will be assessed weekly during radiotherapy, and at 2 and 4 week post treatment.

Late toxicities will be assessed at 3, 6, 9, 12, 18, 24 months post treatment, and annually to 10 years.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, 9
    • St Luke's Radiation Oncology Network at Beaumont Hospital
  • Dublin, Ireland
    • St Luke's Centre for Radiation Oncology at St James Hospital
  • Dublin, Ireland
    • St Luke's Centre for Radiation Oncology at St Lukes Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing pre-operative pelvic chemo-radiotherapy for histologically confirmed rectal adenocarcinoma, with the following staging: cT3N0-2, cT4N0-2, cT(any)N1-2, cT(any)N(any) CRM at-risk [AJCC version V]
• Staging / imaging of pelvis with MRI, and CT Thorax/Abdomen
• No evidence of metastatic disease
• ECOG Performance Status 0 - 2
• Age > or equal to 18 years
• Provision of written informed consent in line with ICH-GCP guidelines

Exclusion Criteria:

• Previous radiotherapy to the pelvic region
• Patients in whom induction chemotherapy has been delivered prior to chemo- radiotherapy
• History of inflammatory bowel disease
• Previous hip replacement
• Previous bowel surgery (excluding procedures/operations which would not result in small bowel adhesions - at the discretion of the Principal Investigator)
• Patients with other syndromes/conditions associated with increased radiosensitivity
• Any other co-existing malignancies within the past 5 years other than non- melanoma skin cancer
• Pregnancy or lactation at the time of proposed randomisation
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study or if it is felt by the research / medical team that the patient may not be able to comply with the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; 50.4 Gy / 28# external beam pelvic radiotherapy delivered using IMRT	Radiation: IMRT; IMRT will be given to some patients to enable comparison of the acute grade 2 GI toxicities compared to those patients receiving their radiotherapy by 3-DCRT
No Intervention: Control Arm; 50.4 Gy / 28# external beam pelvic radiotherapy delivered using a 3-Dimensional (3-D) planned technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in incidence of grade 2 or higher GI toxicity	To determine if there is a reduction in the incidence of grade 2 or higher acute GI toxicity in the IMRT arm, as compared to the Control / 3-D arm, graded by the NCI-CTCAE Version 4	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare incidence of acute grade > 2 GU toxicity	To compare the incidence of acute grade > 2 GU toxicity in the IMRT arm, as compared to the Control / 3-D arm, graded by the NCI-CTCAE Version 4	10 years
Evaluate incidence of late GI and GU toxicity	To evaluate the incidence of late GI and GU toxicity graded by the NCI-CTCAE Version 4	10 years
Rate of loco-regional control	To estimate the rate of loco-regional control by assessing CT / MRI imaging / biopsy	10 years
Assess quality of life	To assess QoL according to the EORTC QLQ-C30 and EORTC QLQ-CR29	10 years
Rate of disease free survival	To estimate the rate of disease-free survival	10 years
Estimate overall survival	To estimate the overall survival rate	10 years
Differences in the toxicity profile between the two types of neoadjuvant concomitant chemotherapy, graded by the NCI-CTCAE Version 4	To compare the differences in the toxicity profile between the two types of neoadjuvant concomitant chemotherapy, graded by the NCI-CTCAE Version 4	10 years

Collaborators and Investigators

• Sponsor: Cancer Trials Ireland
• Investigators: Principal Investigator: Dr Brian O'Neill, MD, St Luke's Centre for Radiation Oncology

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2014
• Primary Completion (Actual): July 21, 2020
• Study Completion (Actual): July 21, 2020

Study Registration Dates

• First Submitted: May 27, 2014
• First Submitted That Met QC Criteria: May 27, 2014
• First Posted (Estimated): May 30, 2014

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: CTRIAL-IE (ICORG) 12-38