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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00002842 |
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Date of registration:
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01/11/1999 |
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Primary sponsor: |
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Public title:
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Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer
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Scientific title:
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Hepatic Resection Followed by Concurrent Adjuvant Portal Vein Infusion of Fluorodeoxyuridine and Systemic 5-Fluorouracil and Folinic Acid for Metastatic Colorectal Carcinoma |
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Date of first enrolment:
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September 1994 |
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Target sample size:
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50 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00002842 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Lucille A. Leong, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beckman Research Institute |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal carcinoma or radiologically confirmed colorectal
carcinoma in a synchronous metastasis
- Intrahepatic metastases required
- No more than 15 metastases involving no more than 60% of functioning liver
- No extrahepatic disease unless:
- Resectable anastomotic or locally recurrent tumor
- Resectable mesenteric lymph node involvement in patients undergoing initial
resection of primary colorectal carcinoma
- Disease extension from liver metastasis amenable to en bloc resection (e.g.,
diaphragm wall, kidney, abdominal wall)
- No biopsy-proven chronic active hepatitis
PATIENT CHARACTERISTICS:
Age:
- Physiologic 18 to 70
Performance status:
- Karnofsky 60%-100%
Hematopoietic:
- AGC at least 1,500
- Platelets at least 100,000
Hepatic:
- Bilirubin no greater than 2.0 mg/dL (unless reversibly obstructed by metastasis)
Renal:
- Creatinine no greater than 2.0 mg/dL
Other:
- No second malignancy within 5 years except adequately treated:
- Nonmelanomatous skin cancer
- In situ bladder cancer
- In situ cervical cancer
- No pregnant women
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Prior mitomycin or nitrosoureas allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to the liver
- At least 3 weeks since radiotherapy and recovered
- Prior pelvic radiotherapy allowed
- No planned concurrent radiotherapy
Surgery:
- Not specified
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Metastatic Cancer
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Intervention(s)
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Drug: floxuridine
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Drug: fluorouracil
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Drug: leucovorin calcium
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Procedure: adjuvant therapy
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Procedure: conventional surgery
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Primary Outcome(s)
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To evaluate the effect of hepatic resection of colorectal carcinoma followed by systemic chemotherapy on 2 year disease free survival .
[Time Frame: 2 years after treatment]
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Secondary ID(s)
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94080
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CDR0000065077
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CHNMC-IRB-94080
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NCI-V96-1031
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P30CA033572
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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