Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer (ERBIRIX)
Drug: Cetuximab, Irinotecan, Capecitabine
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Pre-Operative Concurrent Chemoradiotherapy With Cetuximab, Irinotecan, and Capecitabine in Resectable Rectal Cancer|
- Pathologic stage Tumor regression grade [ Time Frame: After operation ]
- Toxicity measured by NCICTC v3 [ Time Frame: During chemoradiation ]
- Disease-free survival [ Time Frame: Three year ]
|Study Start Date:||May 2006|
|Estimated Study Completion Date:||May 2010|
Daily fractions of radiotherapy at 1.8 Gy to total of 45 Gy to tumor and draining lymph nodes and followed by a coned-down boost of 5.4 Gy to the tumor are delivered concurrently with chemotherapy.
Cetuximab 400 mg/m2 is given intravenously on D-6 (1 week before radiation), followed by 250 mg/m2 once a week (D 1, 8, 15, 22 & 29).
Administration of irinotecan and capecitabine starts on day 1 of radiotherapy. Capecitabine is administered orally at a dose of 825 mg/m2 twice daily during weekdays (Monday to Friday) during radiotherapy. Irinotecan 40 mg/m2 is given intravenously once a week (D 1, 8, 15, 22 & 29).
Four to eight weeks after completion of chemoradiotherapy, curative surgery is performed.
Safety evaluation of the study will be performed after the first 6 patients treated. If more than 1 out of 6 patients received less than 70-80% of planned dose of capecitabine or irinotecan, the dosage of chemotherapy in the further study patients will be adjusted by a protocol amendment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00506844
|Korea, Republic of|
|National Cancer Center Korea|
|Goyang, Gyeonggi, Korea, Republic of, 410-769|
|Seoul National University Bundang Hospital|
|Seongnam, Gyeonggi, Korea, Republic of, 463-707|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Principal Investigator:||Kyung Hae Jung, M.D.Ph.D|