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 range18 Years
SexALL
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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
What they're measuring
1
Reduction in incidence of grade 2 or higher GI toxicity