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

Phase 1

Terminated

• Conditions: Locally Advanced Rectal Cancer
• Interventions: Radiation: IMRT

• Registration Number: NCT02151019
• Lead Sponsor: Cancer Trials Ireland

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.

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 Timeline

• Study First Submitted: 2014-05-27
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-30
• Study Start: 2014-10-17
• Primary Completion: 2020-07-21
• Study Completion: 2020-07-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm	IMRT	50.4 Gy / 28# external beam pelvic radiotherapy delivered using IMRT

Primary Outcome Measures

Name	Time	Method
Reduction in incidence of grade 2 or higher GI toxicity	10 years	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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

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; 🇮🇪 Dublin, Ireland