About this trial
The purpose of this trial is to compare two radiotherapy techniques for treating locally advanced rectal cancer.
It will compare the occurrence of side effects in patients who receive Conventional 3-Dimensional Conformal Radiation Therapy (3-DCRT) with those who receive Intensity Modulated Radiotherapy (IMRT) for treatment of their rectal cancer. We wish to find out if side effects are reduced for these patients when IMRT is used, and we can only fully do so in the context of a clinical research study.
Pre-operative radiotherapy (RT) or chemo-radiotherapy (CRT) is internationally accepted as standard practice in the management of locally advanced rectal cancer. It is not established yet what radiotherapy technique is best to treat this patient group. While both techniques are in use clinically internationally, there needs to be clarification as to which technique offers the best disease control while minimising treatment side-effects.
Every patient in the study will receive the same dose of radiotherapy (50.4 Gy). More specifically, the study aims to determine if 3-DCRT or IMRT results in lower incidence of gastro-intestinal 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 up to 10 years.
Cancer of the rectum which is considered advanced but has not spread elsewhere in the body, who have not yet had surgery (pre-operative).
The trial is open to men and women over 18 years of age who are undergoing pre-operative pelvic chemo-radiotherapy for confirmed rectal cancer. The patient’s cancer must contain a specific type of cancer cells called adenocarcinoma, in order for them to be eligible to participate.
All patients who participate in this study will receive the standard dose of radiation therapy for rectal cancer, however it will be planned according to which arm of the study you are randomised to (3-DCRT or IMRT). The standard duration of treatment is approximately 5 and a half weeks of radiotherapy.
Where’s this trial being run?St Luke’s Radiation Oncology Network @ Beaumont Hospital, St Luke’s Radiation Oncology Network @ St James’s Hospital, and St Luke’s Radiation Oncology Network @ St Luke’s Hospital
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
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Randomised Phase II Clinical Study; 3-D Conformal Chemo-Radiotherapy (current standard) versus IMRT (Intensity Modulated Radiotherapy) for Pre-operative Chemo-Radiotherapy for Locally Advanced Rectal Cancer.
|Principal Investigator:||Dr Brian O' Neill (St Luke's Radiation Oncology Network)|
Cancer Trials Ireland.
Global: Not Applicable
Ireland: August 2014
|Global Recruitment Target:||Not Applicable|
|Ireland Recruitment Target:||268|