Clinical trial NCT01522937: A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
Official title: A Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Cancer
Hepatocellular Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase II trial to characterize the safety and efficacy of individualized stereotactic body radiation therapy (SRBT) for patients who have had previous liver treatment or who have primary hepatocellular carcinoma (HCC).

Detailed description: The trial endpoints are toxicity, survival and progression-free survival. DCE-MRI and plasma biomarkers will also be collected to explore their use as tools for treatment individualization in future trials. During the current trial, an indicator of liver function, indocyanine green (ICG), will be used to identify during treatment patients who are at excess risk for radiation-induced liver disease (RILD) so that their radiation dose may be reduced. The model used for individualization will be updated as trial data accrue, so this is an adaptive trial of an individualized therapy. The planned accrual is seventy (70) evaluable patients over three years.

Eligibility criteria: Inclusion Criteria:

* over age 18
* life expectancy of at least 12 weeks
* Zubrod performance status of ≤2.
* biopsy proven hepatocellular carcinoma (HCC)
* liver metastases
* a discrete hepatic tumor(s) as defined by the Barcelona46 criteria - for cirrhotic patients, (1) 2 imaging studies showing hypervascular tumor \> 2cm, or (2) single imaging study showing hypervascular tumor \> 2cm with AFP ≥ 400 ng/mL
* a discrete hypervascular tumor present on two consecutive imaging studies (CT or MRI) with documented growth of \> 1cm in diameter
* adequate organ function
* women and men not interested in pregnancy
* must be recovered from the effects of any prior surgery, radiation therapy, chemotherapy and the effects of Radiofrequency Ablation (RFA) or Transcatheter Arterial Chemo Embolization (TACE)
* minimum of 6 weeks following their last surgical procedure, radiation and chemotherapy.

Exclusion Criteria:

* cannot be eligible for a curative liver resection
* uncontrolled ascites clinically evident on physical exam
* known allergy to IC-Green
* known allergy to intravenous iodinated contrast agents
* patients with poor venous access
* patients with metastatic cancer with normal liver function who have not undergone previous liver directed therapy and a single tumor \< 6 cm in size.

Primary outcomes:
measure: The Percentage of Patients With Local Control at 1 Year Post Treatment
timeFrame: 1 Year
Secondary outcomes:
measure: The Percentage of Patients Alive Without Progression at 1 Year
timeFrame: 1 Year
measure: The Percentage of Patients Alive at 1 Year
timeFrame: 1 Year
measure: The Number of Patients Who Experience Grade 4+ Hepatotoxicity
timeFrame: 1 Year
measure: The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding
timeFrame: 1 Year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Kyle Cuneo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feng M, Suresh K, Schipper MJ, Bazzi L, Ben-Josef E, Matuszak MM, Parikh ND, Welling TH, Normolle D, Ten Haken RK, Lawrence TS. Individualized Adaptive Stereotactic Body Radiotherapy for Liver Tumors in Patients at High Risk for Liver Damage: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Jan 1;4(1):40-47. doi: 10.1001/jamaoncol.2017.2303.