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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000450766 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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 studying the side effects and best dose of radiation therapy in treating patients with liver metastases.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study.
Patients undergo highly conformal radiotherapy (HCR) to the liver once daily, 5 days a week, for 2 weeks.
Cohorts of 6 patients receive escalating doses of HCR until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation therapy dose level II: 4.0 Gy/fx | Other | Radiation therapy dose level II: 4.0 Gy/fraction |
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| Radiation therapy dose level III: 4.5 Gy/fx | Other | Radiation therapy dose level III: 4.5 Gy/fraction |
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| Radiation therapy dose level IV: 5.0 Gy/fx | Other | Radiation therapy dose level IV: 5.0 Gy/fraction |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiation therapy | Radiation |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximally tolerated dose | From start of treatment to 90 days |
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DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
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
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Alan W. Katz, MD | James P. Wilmot Cancer Center | Principal Investigator |
| Laura A. Dawson, MD | Princess Margaret Hospital, Canada | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States | ||
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Princess Margaret Hospital |
| Toronto |
| Ontario |
| M5G 2M9 |
| Canada |
| McGill Cancer Centre at McGill University | Montreal | Quebec | H2W 1S6 | Canada |