Safety, Efficacy, and Dosing of Stereotactic Radiosurgery for Hepato-cellular Carc/Colo-rectal Liver Metastases

NCT01528878 | Completed Results DMC

• 1 other identifier: LCCC 0809
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine a tolerable dose of radiation delivered by the CyberKnife system in two groups of patients with hepatocellular carcinoma (HCC).

Conditions

Liver Neoplasms; Colonic Neoplasms; Metastatic Cancer to Liver

Keywords

Liver Cancer; Hepatocellular Carcinoma; HCC; Metastatic Cancer to Liver; Metastatic Colon Cancer; Metastatic Colo-rectal Cancer; mCRC; Liver Function; Child-Pugh

Outcome Measures

Primary Outcomes (1)

• Tolerability of Stereotactic Body Radiotherapy (SBRT) Based on Number of Cumulative Acute Toxicities Occurring Within 90 Days of Treatment and Related to SBRT.

  To determine a tolerable dose, cumulative acute toxicity was collected (defined as toxicity occurring within 90 days of treatment initiation). Adverse events were graded by the Common Terminology Criteria for Adverse Events version 3.0. Tolerability was based on hepatic toxicity. A grading (severity) scale is provided for each adverse event (AE) term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

  90 days

Secondary Outcomes (3)

• Local Tumor Control to Doses of Radiation in Patients With Liver Cancer or Metastases to the Liver

  12.7 months

• Percentage of Local Response to Doses of Radiation in Patients With Liver Cancer or Metastases to the Liver

  6 months

• Overall Survival of Patients With Liver Cancer or Metastases to the Liver

  1 year

Study Arms (2)

Good liver function.

EXPERIMENTAL

Patients with good liver function as defined by no more than Child-Pugh Class A.

Radiation: Stereotactic Radiosurgery using the CyberKnife System.

Compromised liver function.

EXPERIMENTAL

Patients with compromised liver function as defined by patients with Child-Pugh Class B.

Radiation: Stereotactic Radiosurgery using the CyberKnife System.

Interventions

Stereotactic Radiosurgery using the CyberKnife System. RADIATION

Radiation: Stereotactic Radiosurgery using the CyberKnife System. The CyberKnife system has been cleared by the U.S. Food and Drug Administration (FDA) to treat lesions, tumors and conditions, anywhere in the body when radiation treatment is indicated. To address movement of target lesion during the respiratory cycle, the Synchrony™ option will be used. The Synchrony option precisely tracks tumors in or near the target organ as they move, enabling the highly focused beams of radiation to destroy the tumors with minimal injury to adjacent normal tissue. The Synchrony option records the breathing movements of a patient's chest and combines that information with sequential x-ray pictures of tiny markers inserted inside or in the proximity of the tumor to enable precise delivery of radiation during any point in the respiration cycle. The CyberKnife system with the Synchrony option enables reduced normal tissue exposure by using smaller treatment margins and increased accuracy.

Also known as: Radiotherapy, CyberKnife, Stereotactic Radiosurgery

Compromised liver function.; Good liver function.

Eligibility Criteria

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

You may qualify if:

• Hepatocellular carcinoma (as defined by biopsy or alpha-fetoprotein (AFP) greater than 1000ng/dL with appropriate imaging) or liver metastases from colorectal cancer or other tumor (as defined by biopsy or elevated Carcinoembryonic antigen (CEA) or a positive positron emission tomography (PET) scan in conjunction with a mass on CT or MRI in a patient with previously resected cancer). Patients with at least one measurable liver lesion and no more than 3 are eligible if they meet all other eligibility criteria including the dose constraints on the composite plan.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Patients are not candidates for definitive surgical resection because of tumor location, hepatic function, or other medical or personal reasons.
• Patients with HCC who are being considered for liver transplant may be entered as a bridge to transplant if it is considered by the transplant team that an ablative therapy would be of value while awaiting transplant.
• If cirrhosis is present, patients will have Child-Pugh score of A or B (see Appendix A in the Master Protocol).
• Patients will have tumors not optimally treated with radio-frequency ablation by interventional radiology, or by GI/transplant surgery. This could be for reasons of size, tumor location, or other reasons.
• Ability to place fiducial markers in the vicinity of the tumor to allow for radiographic tracking of respiratory motion and tumor localization. Fiducial placement will generally be done by interventional radiology.
• Estimates of hepatic tolerance must meet the criteria as defined in Section III. This eligibility will not be able to made definitively until the patient has agreed to participate. in the study and the appropriate scan analyses and dosimetry have been performed. No more than one decrement in dose from the planned dose level will be allowed for an individual patient because of exceeding the maximal liver doses before the patient is declared ineligible for study.
• Adequate bone marrow and renal function as assessed by the following:
• Absolute neutrophil count (ANC) \> 1000/mm3
• Platelet count \> 80,000/mm3
• Creatinine \< 2.0 mg/dL OR Creatinine clearance \> 45 mL/min based on Cockcroft-Gault formula).
• Patients with extra hepatic metastatic disease are eligible if it is the opinion of the treating physician that local therapy to the liver may produce worthwhile clinical benefits
• Patient is able to understand fully the potential risks and benefits of this approach and signs an appropriate informed consent.

You may not qualify if:

• Child-Pugh Class C cirrhosis
• Patients with clinically apparent central nervous system (CNS) disease.
• Medical or psychiatric illness that would not allow the patient to tolerate the proposed treatment including inability to lie flat for an extended period of time, severe claustrophobia or other reasons.
• Uncontrolled or significant cardiovascular disease including: myocardial infarction within 6 months, uncontrolled angina within 6 months, Class III-IV New York Heart Association (NYHA) congestive heart failure, grade 3 cardiac valve dysfunction
• Evidence of decompensated liver disease as evidenced by: clinically significant ascites refractory to diuretic therapy) evidence of hepatic encephalopathy, coagulopathy not corrected by conservative measures.
• A history of CTCAE Grade 3 bleeding esophageal or gastric varices within the past 2 months. Prior variceal bleed permitted if patient has undergone banding or sclerotherapy and there has been no evidence of bleeding for 2 months. Patients at risk for varices (based on the following: known history of esophageal or gastric varices; evidence of hepatic cirrhosis and/or portal hypertension including biopsy-proven cirrhosis, hypersplenism, or radiographic findings of varices) will be screened for esophageal varices. If varices are identified that require intervention (banding), patient will not be eligible until varices adequately treated.
• Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
• Uncontrolled intercurrent illness.
• Inability to comply with study and/or follow-up procedures.
• A patient with Child-Pugh Class A will not be eligible for study if the liver dose constraint described in Section 3.2 cannot be met after two decrements in dose per fraction as described above.
• A patient with Child-Pugh Class B will not be eligible for study if the liver dose constraint described in Section 3.2 cannot be met after two decrements in dose per fraction as described above.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (2)

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

East Carolina Medical School

Greenville, North Carolina, 27858, United States

Location

Related Links

• Website for University of North Carolina Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Liver Neoplasms; Colonic Neoplasms; Carcinoma, Hepatocellular

Interventions

Radiotherapy; Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Robin Johnson
• Organization: UNC Lineberger Comprehensive Cancer Center

robin_v_johnson@med.unc.edu

919-966-1125

Study Officials

• Joel Tepper, MD

  University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: February 8, 2012
• Study Start: April 1, 2009
• Primary Completion: August 18, 2014
• Study Completion: January 28, 2016
• Last Updated: July 26, 2018
• Results First Posted: May 15, 2018

Record last verified: 2018-06

Locations

US (2)