Spots Global Cancer Trial Database for Pre-operative 3-DCRT vs IMRT for Locally Advanced Rectal Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Pre-operative 3-DCRT vs IMRT for Locally Advanced Rectal Cancer

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

Study ID: NCT02151019

Conditions

Locally Advanced Rectal Cancer

Interventions

IMRT

Study Description

Brief 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.

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.