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Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer (ERBIRIX)

Primary Purpose

Rectal Neoplasms, Neoadjuvant Treatment

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cetuximab, Irinotecan, Capecitabine
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms focused on measuring Rectal neoplasms, Neoadjuvant treatment, Cetuximab, Irinotecan, Capecitabine, Radiotherapy, Combination chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer Center Korea
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Asan Medical Center

Outcomes

Primary Outcome Measures

Pathologic stage Tumor regression grade

Secondary Outcome Measures

Toxicity measured by NCICTC v3
Disease-free survival

Full Information

First Posted
July 23, 2007
Last Updated
July 23, 2007
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00506844
Brief Title
Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer
Acronym
ERBIRIX
Official Title
A Phase II Study of Pre-Operative Concurrent Chemoradiotherapy With Cetuximab, Irinotecan, and Capecitabine in Resectable Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms, Neoadjuvant Treatment
Keywords
Rectal neoplasms, Neoadjuvant treatment, Cetuximab, Irinotecan, Capecitabine, Radiotherapy, Combination chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cetuximab, Irinotecan, Capecitabine
Primary Outcome Measure Information:
Title
Pathologic stage Tumor regression grade
Time Frame
After operation
Secondary Outcome Measure Information:
Title
Toxicity measured by NCICTC v3
Time Frame
During chemoradiation
Title
Disease-free survival
Time Frame
Three year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Hae Jung, M.D.Ph.D
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center Korea
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

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Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer

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