Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer (ERBIRIX)
Recruitment status was Active, not recruiting
This study is to estimate the pathologic complete response rate of cetuximab, irinotecan, and capecitabine concurrent with radiotherapy given preoperatively in patients with resectable rectal cancer.
Drug: Cetuximab, Irinotecan, Capecitabine
|Study Design:||Endpoint Classification: Efficacy Study
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.
|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|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Kyung Hae Jung, M.D.Ph.D|