NCT01171300

Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Rectal cancer is a frequent but curable malignancy in the Western world. The golden standard in treating these patients consists of neoadjuvant chemoradiotherapy (CRT) followed by extensive surgery regardless of tumor response. The main question is whether extensive surgery can be avoided holding in mind that already a significant amount of patients reach a pathological complete response after radiochemotherapy. The goal of this study is dual. First of all, the investigators want to investigate the value of DW-MRI and 18FDG-PET in the assessment of response after neoadjuvant CRT in 100 patients with rectal cancer, to select those patients eligible for less invasive surgery. In the same patient group, the investigators will examine the biomarker potential of molecular characteristics of the tumor in blood and tissue. Using both molecular and radiological findings, the investigators want to predict pathological response after chemoradiotherapy and to select patients who may benefit from treatment adjustments during chemoradiotherapy.

Conditions

• Adenocarcinoma
• Rectal Neoplasms

Interventions

Type	Name	Description
OTHER	18F- FDG PET scans	We aim to investigate the value of FGD-PET for evaluating response before surgery. To achieve this, the patients will undergo 3 FDG-PET scans (at moment of diagnosis (staging), during chemoradiation (early response), 1-2 weeks before surgery (restaging))
OTHER	DW-MRI scans	We aim to investigate the value of DW-MRI for evaluating response before surgery. To achieve this, the patients will undergo 3 FDG-PET scans (at moment of diagnosis (staging), during chemoradiation (early response), 1-2 weeks before surgery (restaging))

Timeline

• Start date: 2010-10-01
• Primary completion: 2015-12-01
• Completion: 2025-12-01
• First posted: 2010-07-28
• Last updated: 2024-07-10

Locations

1 site across 1 country: Belgium