NCT00909987

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

Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy With Selective Radiotherapy Use in Patients With Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Grupo Espanol Multidisciplinario del Cancer Digestivo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

XELOX / Bevacizumab will be administrated for 3 cycles over a 9 week period. XELOX without Bevacizumab will be administrated for an additional cycle over a 4 week period. Patients will undergo re-staging within 3 weeks of their 4th cycle of XELOX. This will include MRI of the pelvis. If the reassessment reveals that there has been no disease progression compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection, the patient will proceed to definitive rectal cancer surgery within 4 weeks from the last chemotherapy dose. If the surgical oncologist's reassessment reveals that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous Capecitabine.

Conditions

• Rectum Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine	PO 1000 mg/m2 bid during day 1 to 15 for 3 cycles (every cycle has 3 weeks)
DRUG	Oxaliplatin	IV 130 mg/m2 during day 1 for 3 cycles (every cycle has 3 weeks)
DRUG	Bevacizumab	IV 7.5 mg/Kg during 30 minutes day 1 during 4 cycles (every cycle has 3 weeks)
RADIATION	Radiotherapy	Total dose 50.4 Gy administered during 28 days (1.8 Gy/day in 5 weeks).
DRUG	Capecitabine during all Radiotherapy period	825 mg/m2 bid
PROCEDURE	Total Mesorectal Excision (TME)	4 weeks from the last chemotherapy dose. In those patients who receive radiation TME wil be performed six weeks after

Timeline

• Start date: 2009-03-01
• Primary completion: 2013-01-01
• Completion: 2013-06-01
• First posted: 2009-05-29
• Last updated: 2013-10-11

Locations

12 sites across 1 country: Spain