Pre-operative 3-DCRT vs IMRT for Locally Advanced Rectal Cancer (NCT02151019) | Clinical Trial Compass
TerminatedPhase 1/2
Pre-operative 3-DCRT vs IMRT for Locally Advanced Rectal Cancer
Stopped: Due to futility
Ireland94 participantsStarted 2014-10-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in incidence of grade 2 or higher GI toxicity