Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer

Rectal Neoplasms Clinical Trial

— ERBIRIX  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00506844
• Other study ID #: NCCCTS-06-165
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 23, 2007
• Last updated: July 23, 2007
• Start date: May 2006
• Est. completion date: May 2010

Study information

• Verified date: July 2007
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the rectum

• Distal margin of tumor located from 0 to 8 cm from anal verge

• Stage T3/T4 ± N+ by MRI ± endorectal ultrasonography

• ECOG performance status 0-2

• No prior chemotherapy, radiotherapy to pelvis, immunotherapy, and EGFR pathway targeting therapy

• Adequate organ functions

• Patients must sign the informed consent

Exclusion Criteria:

• Malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease

• Any defined hereditary colorectal cancer

• Any unresected synchronous colon cancer

• R0 resection of tumor is not clinically possible

• Any distant metastasis

• Intestinal obstruction or impending obstruction, but decompressing colostomy is permitted

• Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix

• Any other morbidity or situation with contraindication for chemoradiotherapy

• Patients with history of significant gastric or small bowel resection, or malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of capecitabine

• History of severe pulmonary disease

• Pregnant or lactating women or patients of childbearing potential not predicting adequate contraception

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoadjuvant Treatment
• Rectal Neoplasms

Intervention

Drug:
• Cetuximab, Irinotecan, Capecitabine

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center Korea	Goyang	Gyeonggi
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic stage Tumor regression grade		After operation
Secondary	Toxicity measured by NCICTC v3		During chemoradiation
Secondary	Disease-free survival		Three year