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New radiation technique may ease side effects for rectal cancer patients

NCT ID NCT02151019

Symptom relief Sponsor: Cancer Trials Ireland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared two types of radiation therapy given before surgery for locally advanced rectal cancer. The goal was to see if a newer technique called IMRT causes fewer bowel side effects than the standard 3-D conformal radiotherapy. The trial enrolled 94 patients but was terminated early, so the results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radiation therapy (IMRT vs 3-D conformal radiotherapy)
What this could lead to
If IMRT proves better, it could become the standard way to deliver radiotherapy for rectal cancer, reducing bowel and bladder side effects.
What could go wrong
The trial was terminated early, so results are limited. It is a small, early-phase study, so any benefits are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

94 people

The number who actually took part.

Started

Oct 2014

Finished

Jul 2020

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

rectal cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced rectal cancer

Contacts and locations

Locations

  • 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, 9, Ireland

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