Preoperative Combined Induction Chemotherapy With Capecitabine, Oxaliplatin, Bevacizumab and Radiotherapy

Sponsor
Austrian Breast & Colorectal Cancer Study Group
Study ID
NCT01434147
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Phase II pilot study of a preoperative induction chemotherapy in combination with Bevacizumab followed by combined radiochemotherapy for patients with locally advanced rectal carcinoma

Key Dates

First listed
Sep 14, 2011
Start date
Oct 31, 2011
Status verified
Mar 2014
Primary completion
Aug 31, 2013
Completion
Aug 31, 2013

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: induction chemotherapy + radiochemotherapy
    preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine induction chemotherapy: starts within 28 days after bioptical diagnosis. All patients are administered with capecitabine (Xeloda®) 1000 mg/m2 bid during 14 days (d1-d14), oxaliplatin 130 mg/m2 and bevacizumab (Avastin®) 7.5 mg/kg body weight on day 1; repetition days 22 and 43 (3 cycles) Combined radiochemotherapy: starts at the earliest one week after concluded third cycle of induction chemotherapy. Radiotherapy takes place on 5 x 5 days (dose: 1.8 Gy; cumulative dose: 45 Gy). For chemotherapy patients are administered with capecitabine (Xeloda®) 825mg/m² bid, on each radiation day during the first 4 weeks of radiochemotherapy.

Primary Outcome Measure

termination of therapy [ Time Frame: up to 17 weeks ]

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