Stereotactic Body Radiation Therapy (SBRT) for Liver Mets

NCT01360606 | Completed Results DMC FDA Device

• 1 other identifier: HCC 09-051
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Metastases

Keywords

Stereotactic Body Radiation Therapy (SBRT); standard uptake value (SUV)

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD)

  MTD as determined by dose limiting toxicities (DLT), defined as any grade III stomach, bowel, liver, or spinal cord toxicity, or any grade IV toxicity per RTOG criteria. Only toxicities observed prior to 7 months after the last fraction of radiation were considered. The MTD is the highest dose level at which no more than 1 of 6 treated patients experiences a DLT.

  Up to 16 Months

• Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

  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 Radiation Therapy Oncology Group (RTOG).

  Up to 16 Months

Secondary Outcomes (5)

• Local Control

  Up to 6 years and 4 months (study population)

• Local Response Rate

  Up to 6 years and 4 months (study population)

• FACT-G - Health Related Quality of Life (HRQL) Over Time

  1-2 months, 3-5 months, 6-8 months, 9-11 months,12-14 months,15-17 months, 18-20 months, 21-23 months, 24-26 months

• Functional Assessment of Cancer Therapy-Hepatobiliary Index (FSHI) Over Time

  1-2 months, 3-5 months, 6-8 months, 9-11 months,12-14 months,15-17 months, 18-20 months, 21-23 months, 24-26 months

• FACT-Hep-Trial Outcome Index (TOI)

  1-2 months, 3-5 months, 6-8 months, 9-11 months,12-14 months,15-17 months, 18-20 months, 21-23 months, 24-26 months

Study Arms (1)

SBRT

OTHER

Radiation: Stereotactic Body Radiation Therapy

Interventions

Stereotactic Body Radiation Therapy RADIATION

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.

Also known as: CyberKnife, Trilogy, True Beam, Radiosurgery

SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Susannah Ellsworth: lead

Study Sites (1)

UPMC Hillman Cancer Center - Radiation Oncology

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Barbara Stadterman, MPH, CCRP, Clinical Research Manager
• Organization: UPMC Hillman Cancer Center

stadtermanbm@upmc.edu

4126475554

Study Officials

• Susannah Ellsworth, MD

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 25, 2011
• Study Start: March 23, 2012
• Primary Completion: July 25, 2018
• Study Completion: February 4, 2021
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)