A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer

NCT01522937 | Completed Phase 2 Results DMC

• 2 other identifiers: UMCC 2009-053HUM00029467
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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).

Conditions

Liver Cancer; Hepatocellular Cancer

Outcome Measures

Primary Outcomes (1)

• The Percentage of Patients With Local Control at 1 Year Post Treatment

  For this study, local control is defined as the lack of progressive local disease following CR (Complete Response) or PR (Partial Response), or lack of progressive local disease in patients with non-evaluable disease, who have no progressive elevation in serum tumor markers.

  1 Year

Secondary Outcomes (4)

• The Percentage of Patients Alive Without Progression at 1 Year

  1 Year

• The Percentage of Patients Alive at 1 Year

  1 Year

• The Number of Patients Who Experience Grade 4+ Hepatotoxicity

  1 Year

• The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding

  1 Year

Study Arms (1)

Liver cancer patients

EXPERIMENTAL

The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).

Radiation: individualized Stereotactic Body Radiation Therapy (SBRT)

Interventions

individualized Stereotactic Body Radiation Therapy (SBRT) RADIATION

The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment.

Liver cancer patients

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-5010, United States

Location

Related Publications (1)

• 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.

  PMID: 28796864 DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Dr. Kyle Cuneo, M.D.
• Organization: University of Michigan Comprehensive Cancer Center

kcuneo@umich.edu

734-936-4300

Study Officials

• Kyle Cuneo, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2011
• First Posted: February 1, 2012
• Study Start: October 1, 2009
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 9, 2017
• Results First Posted: March 9, 2017

Record last verified: 2017-01

Locations

US (1)