Pre-operative 3-DCRT vs IMRT for Locally Advanced Rectal Cancer

NCT02151019 | Terminated Phase 1

• 1 other identifier: CTRIAL-IE (ICORG) 12-38
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Locally Advanced Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Compare incidence of acute grade > 2 GU toxicity

  10 years

• Evaluate incidence of late GI and GU toxicity

  10 years

• Rate of loco-regional control

  10 years

• Assess quality of life

  10 years

• Rate of disease free survival

  10 years

Study Arms (2)

Experimental Arm

EXPERIMENTAL

50.4 Gy / 28# external beam pelvic radiotherapy delivered using IMRT

Radiation: IMRT

Control Arm

NO INTERVENTION

50.4 Gy / 28# external beam pelvic radiotherapy delivered using a 3-Dimensional (3-D) planned technique

Interventions

IMRT RADIATION

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

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Trials Ireland: lead

Study Sites (3)

St Luke's Radiation Oncology Network at Beaumont Hospital

Dublin, 9, Ireland

Location

St Luke's Centre for Radiation Oncology at St James Hospital

Dublin, Ireland

Location

St Luke's Centre for Radiation Oncology at St Lukes Hospital

Dublin, Ireland

Location

Study Officials

• Dr Brian O'Neill, MD

  St Luke's Centre for Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 30, 2014
• Study Start: October 17, 2014
• Primary Completion: July 21, 2020
• Study Completion: July 21, 2020
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

IE (3)