Study of Neoadjuvant CT With Selective Radiotherapy in Patients With Intermediate-Risk Cancer Rectum

Phase 2 Completed 46 enrolled Grupo Espanol Multidisciplinario del Cancer Digestivo Royal Marsden NHS Foundation Trust · collab

NaSingle-groupOpen-labelTreatment

Summary

Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy (CAPECITABINE-OXALIPLATIN + BEVACIZUMAB) with Selective Radiotherapy and Chemotherapy with CAPECITABINE Use in Patients with Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging.

Timeline

Start: 2009-03
Primary completion: 2013-01
Completion: 2013-06

Publications

Fernandez-Martos C, Brown G, Estevan R, Salud A, Montagut C, Maurel J, Safont MJ, Aparicio J, Feliu J, Vera R, Alonso V, Gallego J, Martin M, Pera M, Sierra E, Serra J, Delgado S, Roig JV, Santos J, Pericay C. Preoperative chemotherapy in patients with intermediate-risk rectal adenocarcinoma selected by high-resolution magnetic resonance imaging: the GEMCAD 0801 Phase II Multicenter Trial. Oncologist. 2014 Oct;19(10):1042-3. doi: 10.1634/theoncologist.2014-0233. Epub 2014 Sep 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	7.5 mg/kg	Intravenous
Subject	Capecitabine	Small molecule	825 mg/m2	Oral
Subject	Capecitabine	Small molecule	1000 mg/m2	Oral
Subject	Oxaliplatin	Small molecule	130 mg/m2	Intravenous

Study of Neoadjuvant CT With Selective Radiotherapy in Patients With Intermediate-Risk Cancer Rectum

Summary

Timeline

Publications

Drugs

Indications