Locally Advanced Rectal CancerPhase 1/2TRI-LARCNCT02151019
Pre-operative 3-DCRT vs IMRT for Locally Advanced Rectal Cancer
A Phase 1/2 study testing IMRT in people with Locally Advanced Rectal Cancer, run by Cancer Trials Ireland at 3 sites in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 3 sitesIreland
- Study dates
- 17 Oct 2014to 21 Jul 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Ireland3 sites
St Luke's Radiation Oncology Network at Beaumont Hospital
Dublin, 9
St Luke's Centre for Radiation Oncology at St James Hospital
Dublin
St Luke's Centre for Radiation Oncology at St Lukes Hospital
Dublin
About this study
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
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.
Read the 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.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- IMRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRTRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | 50.4 Gy / 28# external beam pelvic radiotherapy delivered using IMRT Receives: Radiation: IMRT |
| Control Arm | No intervention | 50.4 Gy / 28# external beam pelvic radiotherapy delivered using a 3-Dimensional (3-D) planned technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Secondary outcomes (7)
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
Measured: 10 years
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
Measured: 10 years
Rate of loco-regional control
To estimate the rate of loco-regional control by assessing CT / MRI imaging / biopsy
Measured: 10 years
Assess quality of life
To assess QoL according to the EORTC QLQ-C30 and EORTC QLQ-CR29
Measured: 10 years
Rate of disease free survival
To estimate the rate of disease-free survival
Measured: 10 years
Estimate overall survival
To estimate the overall survival rate
Measured: 10 years
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study start17 Oct 2014
- Primary completion21 Jul 2020
- Study completion21 Jul 2020
Why it stopped: Due to futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Dr Brian O'Neill, MD, Principal investigator, St Luke's Centre for Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151019
- Sponsor's protocol ID
- CTRIAL-IE (ICORG) 12-38
- Acronym
- TRI-LARC
- Status last verified
- Apr 2026
- First submitted
- 27 May 2014
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Geary RL, Gillham C, McVey G, Armstrong J, Cunningham M, Rangaswamy G, Sharma D, Wallace N, Skourou C, Dunne M, Mahon M, Bradshaw S, O'Sullivan L, Marron J, Parker I, Shannon AM, McDermott R, Toomey S, Hennessy BT, O'Neill B. Quality-of-Life Analysis of a Phase II Randomised Controlled Trial Comparing Three-Dimensional Conformal Radiotherapy and Intensity-Modulated Radiotherapy in Locally Advanced Rectal Cancer. Clin Oncol (R Coll Radiol). 2025 Jan;37:103695. doi: 10.1016/j.clon.2024.103695. Epub 2024 Nov 20.
PubMed 39693793
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02151019
- Acronym / sponsor ID
- TRI-LARC / CTRIAL-IE (ICORG) 12-38
- Conditions
- Locally Advanced Rectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to futility
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- 17 Oct 2014 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Radiation: IMRT50.4 Gy / 28# external beam pelvic radiotherapy delivered using IMRT |
| Control Arm | No intervention | –50.4 Gy / 28# external beam pelvic radiotherapy delivered using a 3-Dimensional (3-D) planned technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMRTIMRT 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 | Radiation | Experimental Arm |
Primary outcome
Reduction in incidence of grade 2 or higher GI toxicity
Time frame: 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
7 secondary outcomes
Compare incidence of acute grade > 2 GU toxicity
Time frame: 10 years
Evaluate incidence of late GI and GU toxicity
Time frame: 10 years
Rate of loco-regional control
Time frame: 10 years
Assess quality of life
Time frame: 10 years
Rate of disease free survival
Time frame: 10 years
Estimate overall survival
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
Results and safety
The study was stopped early (reason given: Due to futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 39693793Geary RL, Gillham C, McVey G, Armstrong J, Cunningham M, Rangaswamy G, Sharma D, Wallace N, Skourou C, Dunne M, Mahon M, Bradshaw S, O'Sullivan L, Marron J, Parker I, Shannon AM, McDermott R, Toomey S, Hennessy BT, O'Neill B. Quality-of-Life Analysis of a Phase II Randomised Controlled Trial Comparing Three-Dimensional Conformal Radiotherapy and Intensity-Modulated Radiotherapy in Locally Advanced Rectal Cancer. Clin Oncol (R Coll Radiol). 2025 Jan;37:103695. doi: 10.1016/j.clon.2024.103695. Epub 2024 Nov 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Brian O'Neill, MD principal investigator
St Luke's Centre for Radiation Oncology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMRT in people with Locally Advanced Rectal Cancer, run by Cancer Trials Ireland at 3 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in incidence of grade 2 or higher GI toxicity (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02151019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.