A Phase 3 interventional study of Irinotecan and 5-Fluorouracil in Colorectal Cancer, sponsored by Hellenic Oncology Research Group. Completed at 8 sites in Greece. Open to participants aged 18 Years to 72 Years. Per ClinicalTrials.gov, last updated 2010-08-19.
Sponsored by Hellenic Oncology Research Group · Phase 3, Interventional, and Treatment
This phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with the addition of Avastin as 1st line treatment of colorectal cancer.
There is no data of comparison for Folfiri and Xeliri regimens. The reported data demonstrated that the addition of Avastin in the combination of irinotecan/bolus 5-FU/LV has significant improvement of overall survival. Further analysis of these results showed that patients receiving irinotecan in combination with Avastin, as 1st line treatment and oxaliplatin with Avastin, as second line treatment, have median overall survival 25, 1 months, which is the longest survival that has been reported.
5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's planned enrollment of 330 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Hellenic Oncology Research Group is the lead sponsor of 57 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
FOLFIRI/Avastin
Drug: Irinotecan · Drug: 5-Fluorouracil · Drug: Leucovorin · Drug: Bevacizumab
XELIRI/Avastin
Drug: Capecitabine · Drug: Bevacizumab · Drug: Irinotecan
Irinotecan 150mg/m2 IV on day 1 every 2 weeks for 10 cycles
Also known as: CPT-11
5-Fluorouracil 400 mg/m2 infused over 10 min IV and 5-FU 600 mg/m2 infused over 22 hours IV, on Day 1 and 2 (De Grammont regimen), every 2 weeks for 10 cycles
Also known as: 5-FU
Leucovorin 200 mg/m2 infused over 2 hours IV, on day 1 and 2 every 2 weeks for 10 cycles
Also known as: LV
Capecitabine 2000mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
Also known as: Xeloda
Bevacizumab 5mg/kg IV on day 1 every 2 weeks for 10 cycles
Also known as: Avastin
Bevacizumab 7,5mg/kg IV on day 1 every 3 weeks for 6 cycles
Also known as: Avastin
Irinotecan 250mg/m2 IV on day 1 every 3 weeks for 6 cycles
Also known as: CPT-11
Time To Progression
Time frame: 1 year
Objective Response Rate
Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Overall Survival
Time frame: Probability of 1-year survival (%)
Toxicity profile
Time frame: Toxicity assessment on each chemotherapy cycle
Quality of life
Time frame: Assessment every two cycles
Symptoms improvement
Time frame: Assessment every two cycles
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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Hellenic Oncology Research Group