A Phase 1 interventional study of Irinotecan and Capecitabine in Rectal Cancer, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-11-18.
Sponsored by Fudan University · Phase 1, Interventional, and Treatment
Irinotecan is one of effective drugs for colorectal cancer. In neoadjuvant chemoradiotherapy (CRT), Irinotecan is prescribed in a low dose of 50mg/m2/week because of toxicity. Some current studies showed that irinotecan's dose can be increased significantly for those patients with 6/6 or 6/7 genotype of UGT1A1. therefore, the investigators designed this trial to explore the maximal tolerable dose (MTD) of Irinotecan in combined neoadjuvant CRT.
1,804 studies on the registry are indexed under Rectal Neoplasms; 520 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 1,330 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.
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Exclusion Criteria:
irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week
Drug: Irinotecan · Drug: Capecitabine · Radiation: Radiotherapy
initial from 50mg/m2/week and increased by 15mg/m2/week
625mg/m2,bid,d1-5,qw
Also known as: Xeloda
50Gy for whole pelvis
toxicity
* Grade 4 hemato-toxicity * Grade 3 nonhemato-toxicity (not include grade 3 anal verge skin toxicity)
Time frame: 5 weeks
pathological complete response (pCR)
Time frame: within 14days after surgery
The record gives a start of Nov 2011, a primary completion of Nov 2011 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Irinotecan