Clinical Trials/NCT01360606

NCT01360606CompletedNot Applicable

A Phase I Study of Stereotactic Body Radiation Therapy (SBRT) for Liver Metastases

Susannah Ellsworth2 sites in 1 country9 target enrollmentStarted: March 23, 2012Last updated: October 10, 2024

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor
Enrollment: 9
Locations: 2
Primary Endpoint: Maximum Tolerated Dose (MTD)

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Detailed Description

Prior to enrollment all patients will be evaluated with a physical exam, review of pathology and laboratory values to confirm diagnosis, and baseline imaging studies.

Accelerator

Physicians will treat with a stereotactic radiosurgery system using 6MV photons to deliver stereotactic body radiotherapy.

Doses

Patients will receive a total dose ranging from 50-75 Gy in 5 fractions (10-15 Gy/fx). Dose escalation will be via the traditional "up and down" scheme.

Study Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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.
•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

Outcomes

Primary Outcomes

Maximum Tolerated Dose (MTD)

Time Frame: Up to 16 Months

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.

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

Time Frame: Up to 16 Months

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).

Secondary Outcomes

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)

Investigators

Sponsor

Susannah Ellsworth

Sponsor Class

Other

Responsible Party

Sponsor Investigator

Principal Investigator

Susannah Ellsworth

Clinical Associate Professor

University of Pittsburgh

Study Sites (2)

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