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

Locally Advanced Rectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02151019
• Other study ID #: CTRIAL-IE (ICORG) 12-38
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: October 17, 2014
• Est. completion date: July 21, 2020

Study information

• Verified date: April 2023
• Source: Cancer Trials Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 94
• Est. completion date: July 21, 2020
• Est. primary completion date: July 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
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	St Luke's Radiation Oncology Network at Beaumont Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Trials Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Rate of loco-regional control	To estimate the rate of loco-regional control by assessing CT / MRI imaging / biopsy	10 years
Secondary	Assess quality of life	To assess QoL according to the EORTC QLQ-C30 and EORTC QLQ-CR29	10 years
Secondary	Rate of disease free survival	To estimate the rate of disease-free survival	10 years
Secondary	Estimate overall survival	To estimate the overall survival rate	10 years
Secondary	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