Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer (ERBIRIX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00506844
Recruitment Status : Unknown
Verified July 2007 by National Cancer Center, Korea.
Recruitment status was:  Active, not recruiting
First Posted : July 25, 2007
Last Update Posted : July 25, 2007
Information provided by:
National Cancer Center, Korea

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.

Condition or disease Intervention/treatment Phase
Rectal Neoplasms Neoadjuvant Treatment Drug: Cetuximab, Irinotecan, Capecitabine Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2006
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Pathologic stage Tumor regression grade [ Time Frame: After operation ]

Secondary Outcome Measures :
  1. Toxicity measured by NCICTC v3 [ Time Frame: During chemoradiation ]
  2. Disease-free survival [ Time Frame: Three year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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
Sponsors and Collaborators
National Cancer Center, Korea
Principal Investigator: Kyung Hae Jung, M.D.Ph.D Identifier: NCT00506844     History of Changes
Other Study ID Numbers: NCCCTS-06-165
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: July 25, 2007
Last Verified: July 2007

Keywords provided by National Cancer Center, Korea:
Rectal neoplasms
Neoadjuvant treatment
Combination chemotherapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors