Status:
COMPLETED
Radiation Therapy in Treating Patients With Liver Metastases
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase I trial is ...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of high dose per fraction, highly conformal radiotherapy in patients with liver metastases. Secondary * Determine the failure patterns an...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Histologically confirmed non-lymphoma liver metastases
- New radiographic liver lesions most consistent with metastases in a patient with known, histologically proven non-lymphoma cancer AND a previously negative CT scan, MRI, or PET/CT scan of the liver
- No more than 5 measurable lesions by contrast-enhanced liver CT scan, MRI, or PET/CT scan
- Liver metastases ≤ 8 cm
- Medically unfit for surgery OR lesions are surgically unresectable
- All intrahepatic disease must be encompassed within the study radiation field
- Extrahepatic disease outside the liver is allowed provided the hepatic disease is life-limiting
- At least 1,000 cc of normal liver
- No clinical ascites
- No CNS metastases
- PATIENT CHARACTERISTICS:
- Performance status
- Zubrod 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,800/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 8 g/dL (transfusion allowed)
- Hepatic
- No active hepatitis
- No clinically significant liver failure
- No underlying cirrhosis
- Renal
- Not specified
- Cardiovascular
- No congestive heart failure requiring hospitalization within the past 6 months
- No unstable angina pectoris requiring hospitalization within the past 6 months
- No transmural myocardial infarction within the past 6 months
- Pulmonary
- No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the breast, oral cavity, cervix or primary liver metastasis
- No acute bacterial or fungal infection requiring IV antibiotics
- PRIOR CONCURRENT THERAPY:
- Chemotherapy
- At least 4 weeks since prior chemotherapy
- No concurrent chemotherapy
- No anthracyclines within 4 weeks after completion of study therapy (1 week for other chemotherapy)
- Radiotherapy
- No prior radiotherapy to the region of study
- No concurrent intensity-modulated radiotherapy
- Surgery
- Prior liver resection or ablative therapy allowed
- Other
- No concurrent warfarin or IV heparin
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00255814
Start Date
November 1 2005
End Date
November 1 2013
Last Update
November 17 2015
Active Locations (3)
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1
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
3
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6