A Phase 2 interventional study of Preoperative irradiation and Nimotuzumab in Locally Advanced Rectal Cancer, sponsored by Zhejiang Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-07-15.
Sponsored by Zhejiang Cancer Hospital · Phase 2, Interventional, and Treatment
Neoadjuvant (preoperative) concomitant chemoradiotherapy (CRT) is now considered as a standard treatment of locally advanced rectal adenocarcinomas, which correlates better local control and higher sphincter preservation rate. Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR) has been reported to improve the therapeutic effect of radiotherapy in some cancers. This study is a clinical phase II trial designed to evaluate the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, and to further investigate its side-effect and toxicity.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 50 is below the median of 65 across 1,297 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Radiation: Preoperative irradiation · Drug: Nimotuzumab · Drug: Oxaliplatin · Drug: Capecitabine
50.4Gy/28F/5.5w
400mg/w,0-5w
130mg/m2 d1
825mg/m2 bid d1-5/w,1-5w
Pathology complete remission rate
Pathology complete remission rate is the primary outcome measure.
Time frame: 1 year
tumor regression rate
Time frame: 1 year
local recurrence rate
Time frame: 5 years
overall survival
Time frame: 5 years
sphincter preservation rate
Time frame: 3 years
Incidence of Adverse Events
Time frame: up to 1 month after the last cycle
This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Zhejiang Cancer Hospital