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

Primary Purpose

Locally Advanced Rectal Cancer

Status
Terminated
Phase
Phase 1
Locations
Ireland
Study Type
Interventional
Intervention
IMRT
Sponsored by
Cancer Trials Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Luke's Radiation Oncology Network at Beaumont Hospital
  • St Luke's Centre for Radiation Oncology at St James Hospital
  • St Luke's Centre for Radiation Oncology at St Lukes Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Arm

Control Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Rate of loco-regional control
To estimate the rate of loco-regional control by assessing CT / MRI imaging / biopsy
Assess quality of life
To assess QoL according to the EORTC QLQ-C30 and EORTC QLQ-CR29
Rate of disease free survival
To estimate the rate of disease-free survival
Estimate overall survival
To estimate the overall survival rate
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

Full Information

First Posted
May 27, 2014
Last Updated
April 5, 2023
Sponsor
Cancer Trials Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT02151019
Brief Title
Pre-operative 3-DCRT vs IMRT for Locally Advanced Rectal Cancer
Acronym
TRI-LARC
Official Title
Randomised Phase II Study of Pre-operative 3-D Conformal Radiotherapy (3-DCRT) Versus Intensity Modulated Radiotherapy (IMRT) for Locally Advanced Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to futility
Study Start Date
October 17, 2014 (Actual)
Primary Completion Date
July 21, 2020 (Actual)
Study Completion Date
July 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Trials Ireland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
50.4 Gy / 28# external beam pelvic radiotherapy delivered using IMRT
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
50.4 Gy / 28# external beam pelvic radiotherapy delivered using a 3-Dimensional (3-D) planned technique
Intervention Type
Radiation
Intervention Name(s)
IMRT
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduction in incidence of grade 2 or higher GI toxicity
Description
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
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Compare incidence of acute grade > 2 GU toxicity
Description
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
Time Frame
10 years
Title
Evaluate incidence of late GI and GU toxicity
Description
To evaluate the incidence of late GI and GU toxicity graded by the NCI-CTCAE Version 4
Time Frame
10 years
Title
Rate of loco-regional control
Description
To estimate the rate of loco-regional control by assessing CT / MRI imaging / biopsy
Time Frame
10 years
Title
Assess quality of life
Description
To assess QoL according to the EORTC QLQ-C30 and EORTC QLQ-CR29
Time Frame
10 years
Title
Rate of disease free survival
Description
To estimate the rate of disease-free survival
Time Frame
10 years
Title
Estimate overall survival
Description
To estimate the overall survival rate
Time Frame
10 years
Title
Differences in the toxicity profile between the two types of neoadjuvant concomitant chemotherapy, graded by the NCI-CTCAE Version 4
Description
To compare the differences in the toxicity profile between the two types of neoadjuvant concomitant chemotherapy, graded by the NCI-CTCAE Version 4
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Brian O'Neill, MD
Organizational Affiliation
St Luke's Centre for Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Luke's Radiation Oncology Network at Beaumont Hospital
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
St Luke's Centre for Radiation Oncology at St James Hospital
City
Dublin
Country
Ireland
Facility Name
St Luke's Centre for Radiation Oncology at St Lukes Hospital
City
Dublin
Country
Ireland

12. IPD Sharing Statement

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

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