Stereotactic Body Radiation Therapy (SBRT) for Liver Mets

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Dwight Heron, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01360606
First received: May 24, 2011
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

This is a phase I dose escalation study. Dose escalation will be via the traditional "up and down" scheme. SBRT:

Patients will receive one of the following radiation regimens:

  • 50 Gy in 5 fractions (10 Gy/fx) delivered over a 2-week period.
  • 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.
  • 75 Gy in 5 fractions (15 Gy/fx) delivered over a 2-week period.

Condition Intervention Phase
Liver Metastases
Radiation: Stereotactic Body Radiation Therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Stereotactic Body Radiation Therapy (SBRT) for Liver Metastases

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) and safety of SBRT for liver metastases using dose escalation [ Time Frame: 16 Months ] [ Designated as safety issue: Yes ]

    Dose limiting toxicity (DLT) will be defined as any grade III stomach, bowel, liver, or spinal cord toxicity, or any grade IV toxicity as defined by the RTOG. Only toxicities observed prior to 7 months after the last fraction of radiation will affect dose escalation.

    After escalation has stopped, de-escalation will begin at one dose level below the maximum achieved during escalation. If 3 pts have been treated, 3 pts are added; if 6 pts have been treated, this level will be declared the MTD, the highest dose level at which no more than 1 of 6 treated pt experiences a DLT.



Secondary Outcome Measures:
  • Local control associated with this local regional therapy [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    Local control will be defined as stable disease, partial response, or complete response in the target lesion(s). Local failure will be defined as any progression of disease within the target volume. Regional failure will be defined as development of new liver metastases outside of the treated lesions. Distant failure will be defined as development of new metastatic lesions outside of the liver (brain, bone, etc).

  • Local response based on FDG-PET/CT compared to CT alone. [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    Ideally, all follow-up FDG-PET/CT scans after chemo will be performed on the same scanner to help limit variability in the SUVs detected by different scanners. For those patients with non-FDG avid tumors, their response to therapy will be assessed by CT scan. The most recent consensus recommendations by the NCI on assessing PET response indicate semi-quantitative SUV (standard uptake value) analysis based on lean body mass and/or body surface area be used in determining 18F-FDG uptake. We will use the EORTC 1999 criteria for defining 18F-FDG response

  • Health Related Quality of Life (HRQL) associated with this SBRT [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    Health related quality of life will be assessed using the Functional Assessment of Cancer Therapy-Hepatobiliary [FACT-Hep; Appendix V]. The FACT-Hep is part of the Functional Assessment of Chronic Illness Therapy (FACIT; 13) measurement system and includes the FACT-General (FACT-G) and an 18-item module specifically designed for patients diagnosed with hepatobiliary carcinomas.


Estimated Enrollment: 18
Study Start Date: September 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SBRT Radiation: Stereotactic Body Radiation Therapy

SBRT:

Patients will receive one of the following radiation regimens:

  • 50 Gy in 5 fractions (10 Gy/fx) delivered over a 2-week period.
  • 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.
  • 75 Gy in 5 fractions (15 Gy/fx) delivered over a 2-week period.
Other Names:
  • CyberKnife
  • Trilogy
  • True Beam
  • Radiosurgery

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients ≥ 18 years of age
  • A life expectancy of at least 6 months with a Karnofsky performance status of at least 70
  • The target lesion(s) can be accurately measured in at least one dimension according to RECIST and must have a maximum tumor volume of ≤ 100 cm3
  • No prior radiotherapy to the upper abdomen
  • Previous systemic chemotherapy or non-radiation local therapy (such as surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation) is allowed. The lesion must however have shown criteria of progression based on RECIST. Local therapy must be completed at least 4 weeks prior to the baseline scan. This is to create a safer treatment environment and to help determine the effect of treatment by SBRT alone. Patients will be allowed to go onto appropriate systemic therapy, as determined by their medical oncologist, 2 weeks following delivery of SBRT
  • Patients with resectable disease will be eligible for participation if they have comorbidities precluding surgery or refuse to undergo an operation
  • Cirrhotic status of Child-Pugh class A or B
  • Patients can have extra-hepatic disease, provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with surgery, ablative radiation therapy, or US Food and Drug Administration-approved first- or second-line systemic therapy regimens
  • Patient's will have no evidence of gross vascular invasion.
  • Patients will have no more than 3 distinct lesions, all being ≤ 3cm in greatest dimension, OR 1 lesion ≤ 6cm in greatest dimension
  • Platelet count ≥ 60 x 109/L, Hemoglobin ≥ 8.5 g/dL, WBC ≥ 2000/μL International normalized ratio (INR) must be ≤ 2.3. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists
  • Other baseline labs must meet the following criteria: total bilirubin < 3mg/dl, albumin> 2.5mg/dl, and liver enzymes less than three times the upper limit of normal. Creatinine must also be < 1.8mg/dl or a creatinine clearance > 50ml/min
  • Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts

Exclusion Criteria:

  • Renal failure requiring hemo- or peritoneal dialysis
  • Uncontrolled inter-current illness including, but not limited to ongoing or active infection (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 4.0), congestive heart failure (> New York Heart Association (NYHA) class 2), active coronary artery disease (CAD), cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), uncontrolled hypertension and any condition which could jeopardize the safety of the patient and his/her compliance in the study . Myocardial infarction more than 6 months prior to study entry is permitted
  • A history of variceal bleeding where the varices have not been eradicated or decompressed by shunt placement
  • History of an active connective tissue disorder
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Pregnant or breast-feeding patients are excluded from this study because abdominal radiation therapy has potential for teratogenic and/or abortifacient effects
  • Portal vein occlusion
  • Extensive liver tumor burden, defined as more than 75% of the liver.
  • Patients with primary tumor histology of lymphoma, leukemia, or germ cell tumor
  • Patients with hepatocellular carcinoma will be excluded from this study
  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: NCT01360606

Contacts
Contact: Dwight E Heron, MD 412-623-6720 herond2@upmc.edu
Contact: Karen D Holeva 412-623-1275 holevakd@upmc.edu

Locations
United States, Pennsylvania
UPMC Cancer Centers Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Dwight E Heron, MD    412-623-6720    herond2@upmc.edu   
Contact: Karen D Holeva    412-623-1275    holevakd@upmc.edu   
Sub-Investigator: Steven A Burton, MD         
Sub-Investigator: Allan Tsung, MD         
Sub-Investigator: David Gellar, MD         
Sub-Investigator: J. Wallace Marsh, MD         
Sub-Investigator: Melvin Deutsch, MD         
Sub-Investigator: John Flickinger, MD         
Sub-Investigator: Annette E Quinn, MSN         
Sub-Investigator: James M Mountz, MD         
Sub-Investigator: Jennifer Steel, PhD         
Sub-Investigator: Hong Wang, PhD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Dwight E Heron, MD UPMC Shadyside
Principal Investigator: Rodney Wegner, MD UPMC Shadyside
  More Information

No publications provided

Responsible Party: Dwight Heron, Vice Chairman, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01360606     History of Changes
Other Study ID Numbers: 09-051
Study First Received: May 24, 2011
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Liver
Mets

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

ClinicalTrials.gov processed this record on September 18, 2014