- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00506844
Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer (ERBIRIX)
A Phase II Study of Pre-Operative Concurrent Chemoradiotherapy With Cetuximab, Irinotecan, and Capecitabine in Resectable Rectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 138-736
- Asan Medical Center
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Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
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Gyeonggi
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Goyang, Gyeonggi, Korea, Republic of, 410-769
- National Cancer Center Korea
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Seongnam, Gyeonggi, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pathologic stage Tumor regression grade
Time Frame: After operation
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After operation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicity measured by NCICTC v3
Time Frame: During chemoradiation
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During chemoradiation
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Disease-free survival
Time Frame: Three year
|
Three year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kyung Hae Jung, M.D.Ph.D
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Topoisomerase I Inhibitors
- Capecitabine
- Irinotecan
- Cetuximab
Other Study ID Numbers
- NCCCTS-06-165
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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