Stereotactic Body Radiation Therapy in Liver Cancer That Cannot be Removed by Surgery or Transplant

NCT01194206 | Withdrawn Phase 2 DMC

• 2 other identifiers: CASE3209NCI-2010-01883
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue in patients with liver cancer. Giving stereotactic body radiation therapy may also increase patient eligibility for liver transplant.PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with liver cancer that cannot be removed by surgery or transplant.

Conditions

Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of downstaging of stage B and C Hepatocellular Carcinoma using Stereotactic Body Radiotherapy

  At 3 months

Secondary Outcomes (4)

• Rate of Grade 3 or 4 adverse events associated with SBRT for liver tumors as assessed by NCI CTCAE version 4.0

  Baseline, at 1 month, 3 months and 6 months

• Rate of local progression as assessed by RECIST criteria

  Baseline, at 1 month, 3 months and 6 months

• Number of patients who achieve liver transplantation

  at 6 months after SBRT

• Survival rate

  Survival will be measured from the first day of treatment on study until death of any cause.

Study Arms (1)

Arm I

EXPERIMENTAL

Patients undergo 3 fractions of stereotactic body radiation therapy in 3 fractions delivered within 14 days in the absence of disease progression or unacceptable toxicity.

Radiation: stereotactic body radiation therapy

Interventions

stereotactic body radiation therapy RADIATION

At least 3 gold standard Cyberknife fiducials will be placed in the liver w/in 6 cm of the tumor for image guidance during radiation therapy. At least 1 wk will elapse between fiducial placement and tx planning simulation to allow for fiducial settling and any migration.The full radiation tx will be given ideally in 3 consecutive days. In any case there must be a minimum of 24 hrs between fractions and all 3 fractions will be delivered w/in 14 days. The dose to at least 95% of the tumor will be 37.5 Gy total in 12.5 Gy fractions.

Also known as: SBRT, stereotactic radiation therapy, stereotactic radiotherapy

Arm I

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCC is staged as Barcelona B or C (non-resectable and non-transplantable)
• Treatment with SBRT can occur within 6 weeks of staging laparoscopy
• Patient has a) Radiographic enhancing liver lesions on triple phase CT or MRI and b) Histological confirmation of HCC

You may not qualify if:

• Total aggregate of maximal dimension of liver tumors =\< 8 cm
• Cirrhotic patients Child Pugh Class A or B
• Patient should be medically eligible for liver transplantation
• Absolute neutrophil count \> 1,500/ul
• Platelets \> 50,000 ul (after transfusion if required)
• Hemoglobin greater than 10.0 g/dL
• Total bilirubin \< 2.0 mg/dL
• AST(SGOT)/ALT(SGPT) \< 2 X institutional upper limit of normal
• Life expectancy \> 12 weeks
• ECOG performance status \< 2 or Karnofsky \>= 70%
• Women of child-bearing potential must have a negative pregnancy test within 4 weeks to the start of the SBRT treatment
• Women must not be pregnant or nursing
• Sexually active men and women must agree to use accepted forms of birth control
• Provision of informed consent: Patient must be able to provide verbal and written informed consent
• Patient with previous history of abdominal radiation

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Juan Sanabria

  Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

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 1, 2010
• First Posted: September 2, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 18, 2012

Record last verified: 2012-04