Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer - Full Text View

Sponsored by:	National Cancer Center, Korea
Information provided by:	National Cancer Center, Korea
ClinicalTrials.gov Identifier:	NCT00506844

Purpose

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	Intervention	Phase
Rectal Neoplasms Neoadjuvant Treatment	Drug: Cetuximab, Irinotecan, Capecitabine	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Irinotecan Irinotecan hydrochloride Capecitabine Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	A Phase II Study of Pre-Operative Concurrent Chemoradiotherapy With Cetuximab, Irinotecan, and Capecitabine in Resectable Rectal Cancer

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:

Pathologic stage Tumor regression grade [ Time Frame: After operation ]

Secondary Outcome Measures:

Toxicity measured by NCICTC v3 [ Time Frame: During chemoradiation ]
Disease-free survival [ Time Frame: Three year ]

Enrollment:	40
Study Start Date:	May 2006
Estimated Study Completion Date:	May 2010

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506844

Locations

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Korea, Republic of, Gyeonggi
National Cancer Center Korea
Goyang, Gyeonggi, Korea, Republic of, 410-769
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of, 463-707

Sponsors and Collaborators

National Cancer Center, Korea

Investigators

Principal Investigator:

Kyung Hae Jung, M.D.Ph.D

Unaffiliated

More Information

Study ID Numbers:	NCCCTS-06-165
Study First Received:	July 23, 2007
Last Updated:	July 23, 2007
ClinicalTrials.gov Identifier:	NCT00506844
Health Authority:	Korea: Food and Drug Administration

Keywords provided by National Cancer Center, Korea:

Rectal neoplasms
Neoadjuvant treatment
Cetuximab
Irinotecan

Capecitabine
Radiotherapy
Combination chemotherapy

Study placed in the following topic categories:

Capecitabine
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Cetuximab
Irinotecan
Intestinal Diseases

Rectal Diseases
Intestinal Neoplasms
Rectal neoplasm
Digestive System Diseases
Gastrointestinal Neoplasms
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009