A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases
18 Years
N/A
Both
Metastatic Cancer
Trial Information
A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases
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 and survival of patients treated with this regimen.
- Correlate dose-volume characteristics with possible toxic effects of this regimen in
these patients.
- Determine the local control rate within irradiated fields in patients treated with this
regimen.
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the maximally tolerated dose
Outcome Time Frame:
From start of treatment to 90 days
Safety Issue:
Yes
Principal Investigator
Alan W. Katz, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
James P. Wilmot Cancer Center
Authority:
United States: Federal Government
Study ID:
RTOG-0438
NCT ID:
NCT00255814
Start Date:
November 2005
Completion Date:
Related Keywords:
- Metastatic Cancer
- liver metastases
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
- Liver Neoplasms
Name | Location |
|---|---|
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
