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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 April 2023
• Main ID: NCT02151019
• Date of registration: 27/05/2014
• Prospective Registration: Yes
• Primary sponsor: Cancer Trials Ireland
• Public title: Pre-operative 3-DCRT vs IMRT for Locally Advanced Rectal Cancer TRI-LARC
• Scientific title: Randomised Phase II Study of Pre-operative 3-D Conformal Radiotherapy (3-DCRT) Versus Intensity Modulated Radiotherapy (IMRT) for Locally Advanced Rectal Cancer
• Date of first enrolment: October 17, 2014
• Target sample size: 94
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02151019
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Ireland

Contacts

• Name: Dr Brian O'Neill, MD
• Affiliation: St Luke's Centre for Radiation Oncology

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Locally Advanced Rectal Cancer

Intervention(s)

Radiation: IMRT

Primary Outcome(s)

Reduction in incidence of grade 2 or higher GI toxicity [Time Frame: 10 years]

Secondary Outcome(s)

Compare incidence of acute grade > 2 GU toxicity [Time Frame: 10 years]

Estimate overall survival [Time Frame: 10 years]

Evaluate incidence of late GI and GU toxicity [Time Frame: 10 years]

Rate of disease free survival [Time Frame: 10 years]

Assess quality of life [Time Frame: 10 years]

Rate of loco-regional control [Time Frame: 10 years]

Differences in the toxicity profile between the two types of neoadjuvant concomitant chemotherapy, graded by the NCI-CTCAE Version 4 [Time Frame: 10 years]

Secondary ID(s)

CTRIAL-IE (ICORG) 12-38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors