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Radiation Therapy in Treating Patients With Liver Metastases

Primary Purpose

Metastatic Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
radiation therapy
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring liver metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Princess Margaret Hospital
  • McGill Cancer Centre at McGill University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Radiation therapy dose level II: 4.0 Gy/fx

Radiation therapy dose level III: 4.5 Gy/fx

Radiation therapy dose level IV: 5.0 Gy/fx

Arm Description

Radiation therapy dose level II: 4.0 Gy/fraction

Radiation therapy dose level III: 4.5 Gy/fraction

Radiation therapy dose level IV: 5.0 Gy/fraction

Outcomes

Primary Outcome Measures

To determine the maximally tolerated dose

Secondary Outcome Measures

Full Information

First Posted
November 18, 2005
Last Updated
November 14, 2015
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00255814
Brief Title
Radiation Therapy in Treating Patients With Liver Metastases
Official Title
A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 studying the side effects and best dose of radiation therapy in treating patients with liver metastases.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
liver metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation therapy dose level II: 4.0 Gy/fx
Arm Type
Other
Arm Description
Radiation therapy dose level II: 4.0 Gy/fraction
Arm Title
Radiation therapy dose level III: 4.5 Gy/fx
Arm Type
Other
Arm Description
Radiation therapy dose level III: 4.5 Gy/fraction
Arm Title
Radiation therapy dose level IV: 5.0 Gy/fx
Arm Type
Other
Arm Description
Radiation therapy dose level IV: 5.0 Gy/fraction
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
To determine the maximally tolerated dose
Time Frame
From start of treatment to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan W. Katz, MD
Organizational Affiliation
James P. Wilmot Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura A. Dawson, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Study Chair
Facility Information:
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
McGill Cancer Centre at McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada

12. IPD Sharing Statement

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Radiation Therapy in Treating Patients With Liver Metastases

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