Status:
UNKNOWN
Chemotherapy and Internal Radiation in Treating Patients With Colorectal Cancer That Has Spread to the Liver
Lead Sponsor:
Goshen Health System
Conditions:
Colorectal Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Internal radiation uses radioactive mater...
Detailed Description
OBJECTIVES: Primary * Evaluate the tumor response, as measured by total tumor mass, carcinoembryonic antigen (CEA) level, measurable tumor volume by CT scan, and metabolic response by positron emiss...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed colorectal cancer\* meeting 1 of the following criteria:
- Metachronous metastasis after resection of Dukes A-C (i.e., stage I-III) primary colon cancer with or without adjuvant chemotherapy
- Metachronous metastasis after resection of primary rectal cancer with neoadjuvant or adjuvant chemotherapy
- Synchronous metastatic liver disease with symptomatic or asymptomatic primary colorectal cancer NOTE: \*If the patient has a second malignancy with liver metastasis potential, histologic or cytologic confirmation of the liver lesions may be performed as clinically indicated
- Liver-only or liver-predominant disease with any of the following:
- Unresected primary disease
- Limited bone or lung disease
- Potentially resectable nodal disease
- Anastomotic disease
- No active CNS metastasis or diffuse peritoneal metastasis
- No hepatic metastases from a second malignancy
- No predominant extrahepatic disease
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy \> 3 months
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL
- WBC ≥ 1,500/mm\^3
- Creatinine ≤ 2 mg/dL
- Bilirubin ≤ 2 mg/dL (without extrahepatic biliary obstruction)
- Albumin \> 2 g/dL
- INR \< 1.5 (without anticoagulation)
- Not pregnant or nursing
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior external-beam radiotherapy to the liver
- Concurrent targeted therapy agents (e.g., bevacizumab or cetuximab) allowed
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00408551
Start Date
November 1 2005
Last Update
December 19 2013
Active Locations (1)
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1
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States, 46526