Radiation Therapy in Treating Patients With Liver Metastases

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00255814
First received: November 18, 2005
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Metastatic Cancer
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • To determine the maximally tolerated dose [ Time Frame: From start of treatment to 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: November 2005
Study Completion Date: November 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255814

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

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00255814     History of Changes
Other Study ID Numbers: RTOG-0438, CDR0000450766
Study First Received: November 18, 2005
Last Updated: January 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
liver metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Liver Neoplasms
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 29, 2014