We presumed that the addition of a monoclonal antibody Bevacizumab into radiation therapy and combination chemotherapy could results in improved pathologic tumor regression grade (TRG) in locally advanced nonmetastatic rectal cancer.
Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Giving bevacizumab together with radiation therapy and combination chemotherapy before surgery may achieve promising improvements in pCR rates, we designed this Phase II study in patients with T3/4 or N1/2 loco-regionally advanced rectum cancer, to examine the efficacy and safety of the addition of bevacizumab to a regimen of capecitabine and oxaliplatin in combination with pre-operative radiation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning, 8 cycles
iv, 130mg/m2, day 1, 1 cycle during neoadjuvant chemotherapy and 3 cycles in adjuvant chemotherapy 100mg/m2, day 1, 2 cycles during concurrent chemoradiotherapy
iv, 7.5 mg/kg, day 1, 3 cycles during neoadjuvant chemotherapy and concurrent chemoradiotherapy
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, China
RECRUITINGThe pathologic tumor regression grade (TRG)
Time frame: March 30, 2015
5-y overall survival
Time frame: March 30, 2020
Occurence of toxicity
Time frame: March 30, 2015
5-y local relapse free survival
Time frame: March 30, 2020
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Intensity-modulated radiation therapy, 50 Gy/25 fractions during 5 weeks
Total Mesorectal Excision (TME)