NCT00828672

Neoadjuvant Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin Locally Advanced Rectal Cancer

A Randomized Phase II Study of Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin in the Preoperative Treatment of Locally Advanced Rectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly multinational). Academic, investigator initiated. To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM) and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment of locally advanced rectal cancer, followed by TME (total mesorectal excision).

Detailed description

See Synopsis

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin	Administered on days 15,22,29,36 en 43; 50 mg/m2
DRUG	Bevacizumab	Administered on days 1,15,29 and 43 ; 5mg/kg
DRUG	Capecitabine	825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy
RADIATION	radiotherapy	Total dose 45Gy

Timeline

• Start date: 2009-06-01
• Primary completion: 2014-03-01
• Completion: 2019-03-01
• First posted: 2009-01-26
• Last updated: 2019-07-10
• Results posted: 2019-07-10

Locations

9 sites across 1 country: Belgium