Spots Global Cancer Trial Database for Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer

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Trial Identification

Brief Title: Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer

Official Title: A Phase II Study of Pre-Operative Concurrent Chemoradiotherapy With Cetuximab, Irinotecan, and Capecitabine in Resectable Rectal Cancer

Study ID: NCT00506844

Conditions

Rectal Neoplasms

Neoadjuvant Treatment

Interventions

Cetuximab, Irinotecan, Capecitabine

Study Description

Brief Summary: 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.

Detailed Description: 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.