Radiation Therapy in Treating Patients With Liver Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00255814
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : November 17, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

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.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Radiation: radiation therapy Phase 1

Detailed Description:



  • Determine the maximum tolerated dose of high dose per fraction, highly conformal radiotherapy in patients with liver metastases.


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases
Study Start Date : November 2005
Actual Primary Completion Date : September 2011
Actual Study Completion Date : November 2013

Arm Intervention/treatment
Radiation therapy dose level II: 4.0 Gy/fx
Radiation therapy dose level II: 4.0 Gy/fraction
Radiation: radiation therapy
Radiation therapy dose level III: 4.5 Gy/fx
Radiation therapy dose level III: 4.5 Gy/fraction
Radiation: radiation therapy
Radiation therapy dose level IV: 5.0 Gy/fx
Radiation therapy dose level IV: 5.0 Gy/fraction
Radiation: radiation therapy

Primary Outcome Measures :
  1. To determine the maximally tolerated dose [ Time Frame: From start of treatment to 90 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,800/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8 g/dL (transfusion allowed)


  • No active hepatitis
  • No clinically significant liver failure
  • No underlying cirrhosis


  • Not specified


  • 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


  • No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy


  • 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



  • 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)


  • No prior radiotherapy to the region of study
  • No concurrent intensity-modulated radiotherapy


  • Prior liver resection or ablative therapy allowed


  • No concurrent warfarin or IV heparin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00255814

United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Alan W. Katz, MD James P. Wilmot Cancer Center
Study Chair: Laura A. Dawson, MD Princess Margaret Hospital, Canada

Responsible Party: Radiation Therapy Oncology Group Identifier: NCT00255814     History of Changes
Other Study ID Numbers: RTOG-0438
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Keywords provided by Radiation Therapy Oncology Group:
liver metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes