A Phase 2 interventional study of Xeloda and Oxaliplatin in Rectal Cancer, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-06-08.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 45 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
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Exclusion Criteria:
cerebrovascular accidents (\<=6 months), myocardial infarction (\<= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.
Neoadjuvant chemotherapy with XELOX: Xeloda, po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning; Oxaliplatin, iv, 130mg/m2, day 1; and Bevacizumab, iv, 7.5 mg/kg, day 1, during the first cycle (each cycle has 3 weeks). Followed by chemoradiotherapy, 50 Gy/25 fractions during 5 weeks plus 2 cycles XELOX and Bevacizumab: Xeloda, po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning; Oxaliplatin, iv, 100mg/m2, day 1; and Bevacizumab, iv, 7.5 mg/kg, day 1. 6-7 weeks from the last radiation therapy, Total Mesorectal Excision (TME) surgery will be performed. 3-4 weeks after operation, 3 cycles XELOX (the same as the neoadjuvant chemotherapy) and 2 cycles Xeloda (po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning) will be administered.
Drug: Xeloda · Drug: Oxaliplatin · Drug: Bevacizumab · Radiation: Radiation · Procedure: surgery
po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning, 8 cycles
Also known as: Capecitabine
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
Also known as: Avastin
Intensity-modulated radiation therapy, 50 Gy/25 fractions during 5 weeks
Total Mesorectal Excision (TME)
The 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
This study is status unknown, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University