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Radiation Therapy in Treating Patients With Liver Metastases

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00255814
First Posted: November 21, 2005
Last Update Posted: November 17, 2015
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
November 18, 2005
November 21, 2005
November 17, 2015
November 2005
September 2011   (Final data collection date for primary outcome measure)
To determine the maximally tolerated dose [ Time Frame: From start of treatment to 90 days ]
Not Provided
Complete list of historical versions of study NCT00255814 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Radiation Therapy in Treating Patients With Liver Metastases
A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases

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

  • 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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Cancer
Radiation: radiation therapy
  • Radiation therapy dose level II: 4.0 Gy/fx
    Radiation therapy dose level II: 4.0 Gy/fraction
    Intervention: Radiation: radiation therapy
  • Radiation therapy dose level III: 4.5 Gy/fx
    Radiation therapy dose level III: 4.5 Gy/fraction
    Intervention: Radiation: radiation therapy
  • Radiation therapy dose level IV: 5.0 Gy/fx
    Radiation therapy dose level IV: 5.0 Gy/fraction
    Intervention: Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
November 2013
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00255814
RTOG-0438
CDR0000450766
Yes
Not Provided
Not Provided
Radiation Therapy Oncology Group
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
Radiation Therapy Oncology Group
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP