Radiation Therapy in Treating Patients With Liver Metastases

November 14, 2015 updated by: Radiation Therapy Oncology Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill Cancer Centre at McGill University
  • United States
    • New York
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Radiation therapy dose level II: 4.0 Gy/fx
Radiation therapy dose level II: 4.0 Gy/fraction
Radiation: radiation therapy
Other: Radiation therapy dose level III: 4.5 Gy/fx
Radiation therapy dose level III: 4.5 Gy/fraction
Radiation: radiation therapy
Other: Radiation therapy dose level IV: 5.0 Gy/fx
Radiation therapy dose level IV: 5.0 Gy/fraction
Radiation: radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the maximally tolerated dose
Time Frame: From start of treatment to 90 days
From start of treatment to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Alan W. Katz, MD, James P. Wilmot Cancer Center
  • Study Chair: Laura A. Dawson, MD, Princess Margaret Hospital, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

November 18, 2005

First Submitted That Met QC Criteria

November 18, 2005

First Posted (Estimate)

November 21, 2005

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 14, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTOG-0438
  • CDR0000450766

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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