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Stereotactic Radiation Therapy in Treating Patients With Advanced Liver Cancer

Primary Purpose

Liver Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

stereotactic body radiation therapy

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer

Eligibility Criteria

19 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC)
Measurable disease, defined as ≥ 1 unidimensionally target lesion that can be accurately measured by CT scan or MRI according to RECIST and must have a maximum diameter ≤ 8 cm
No known CNS tumors, including metastatic brain disease
Child-Pugh class A-B cirrhotic status

PATIENT CHARACTERISTICS:

Karnofsky performance status 60-100%
Life expectancy ≥ 12 weeks
WBC ≥ 2,000/μL
Platelet count ≥ 60,000/mm³
Hemoglobin ≥ 8.5 g/dL
INR ≤ 2.3
No malignancy within the past 3 years that is distinct in its primary site or histology from HCC, except for carcinoma in situ of the cervix, treated basal cell carcinoma, or superficial bladder tumors (i.e., Ta, Tis, and T1), or any other cancer that has been curatively treated > 3 years prior to study entry
No renal failure requiring hemodialysis or peritoneal dialysis
No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection > grade 2
- NYHA class II-IV congestive heart failure
- Active coronary artery disease
- Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
- Uncontrolled hypertension
- Condition that could jeopardize the safety of the patient or study compliance
More than 6 months since prior myocardial infarction
No history of variceal bleeding where the varices have not been eradicated or decompressed by shunt placement
No condition that would prevent the patient from undergoing marker implantation
Not pregnant or nursing
Negative pregnancy test
No substance abuse, medical, psychological, or social condition that may interfere with the patient's participation in the study or evaluation of the study results

PRIOR CONCURRENT THERAPY:

Prior systemic chemotherapy allowed
At least 6 weeks since prior non-radiation local therapy (e.g., surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation)
No prior radiotherapy to the liver
Concurrent therapeutic anticoagulation (e.g., warfarin or heparin) allowed provided that no prior evidence of underlying abnormality in PT, PTT, INR exists

Sites / Locations

University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypofractionated stereotactic radiotherapy (SRT)

Arm Description

All patients who have had successful implantation of a liver marker will undergo a 4D CT scan for planning SRT. Following transfer to the treatment planning system, the CT scan may be correlated by imaging fusion with MRI for contouring integrated tumor volume (ITV). The planning target volume (PTV) will be defined as ITV plus individualized margins which are determined by a 4D CT scan. Novalis with 6MV photons will be used for imaging guided SRT. Cohorts of 3-6 patients will receive SRT at daily doses of 8, 10, 12, 14 Gy within 2 weeks. The starting daily dose level will be 10 Gy. The marker will be localized by orthogonal X-ray to ensure reproducibility. A continuous respiratory gating will be accomplished with ExacTrac Adaptive Gating system if the required planning target margin is larger than 1 cm based on the 4D CT data.

Outcomes

Primary Outcome Measures

Toxicity as assessed by NCI CTCAE v3.0

Maximum tolerated dose

Secondary Outcome Measures

Full Information

NCT ID

NCT00607828

First Posted

February 1, 2008

Last Updated

October 7, 2023

Sponsor

University of Nebraska

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00607828

Brief Title

Stereotactic Radiation Therapy in Treating Patients With Advanced Liver Cancer

Official Title

Feasibility of Hypofractionated Stereotactic Radiotherapy in Patients With Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

November 16, 2007 (Actual)

Primary Completion Date

February 15, 2017 (Actual)

Study Completion Date

February 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Nebraska

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with advanced liver cancer.

Detailed Description

OBJECTIVES: Primary To determine the safety of hypofractionated stereotactic radiotherapy (SRT) in patients with advanced hepatocellular carcinoma. Secondary To determine the maximum tolerated dose of SRT in these patients. To determine the objective tumor response rate in terms of the percentage of tumor size change on CT, percentage of intensity change on MRI, and the percentage of change in alfa fetoprotein in patients treated with this therapy. To determine the value of 4-dimensional CT in liver cancer planning in terms of the extent of liver motion (three dimensionally) and the percentage of patients requiring breath gating due to the amplitude of organ motion exceeding 1 cm in any dimension. To determine the value of breath gating in liver cancer SRT in terms of the success rate of breath gating and the percentage of treatment time prolongation secondary to the gating. OUTLINE: Patients undergo hypofractionated stereotactic radiotherapy once daily on days 1-5. After completion of study therapy, patients are followed at 1 and 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cancer

Keywords

adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hypofractionated stereotactic radiotherapy (SRT)

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

stereotactic body radiation therapy

Intervention Description

Undergo radiotherapy

Primary Outcome Measure Information:

Title

Toxicity as assessed by NCI CTCAE v3.0

Description

Toxicity as assessed by NCI CTCAE v3.0

Time Frame

Up to 1 month after SRT

Title

Maximum tolerated dose

Description

Maximum tolerated dose

Time Frame

At least 1 month of observation after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC) Measurable disease, defined as ≥ 1 unidimensionally target lesion that can be accurately measured by CT scan or MRI according to RECIST and must have a maximum diameter ≤ 8 cm Child-Pugh class A-B cirrhotic status Karnofsky performance status 60-100% Life expectancy ≥ 12 weeksWBC ≥ 2,000/μL Platelet count ≥ 60,000/mm³ Hemoglobin ≥ 8.5 g/dLINR ≤ 2.3 More than 6 months since prior myocardial infarction Prior systemic chemotherapy allowed At least 6 weeks since prior non-radiation local therapy (e.g., surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) Concurrent therapeutic anticoagulation (e.g., warfarin or heparin) allowed provided that no prior evidence of underlying abnormality in PT, PTT, INR exists Exclusion Criteria: No known CNS tumors, including metastatic brain disease No malignancy within the past 3 years that is distinct in its primary site or histology from HCC, except for carcinoma in situ of the cervix, treated basal cell carcinoma, or superficial bladder tumors (i.e., Ta, Tis, and T1), or any other cancer that has been curatively treated > 3 years prior to study entry No renal failure requiring hemodialysis or peritoneal dialysis No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection > grade 2 NYHA class II-IV congestive heart failure Active coronary artery disease Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin Uncontrolled hypertension Condition that could jeopardize the safety of the patient or study compliance No history of variceal bleeding where the varices have not been eradicated or decompressed by shunt placement No condition that would prevent the patient from undergoing marker implantation Not pregnant or nursing/negative pregnancy test No substance abuse, medical, psychological, or social condition that may interfere with the patient's participation in the study or evaluation of the study results No prior radiotherapy to the liver

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chi Lin, MD, PhD

Organizational Affiliation

University of Nebraska

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198-6805

Country

United States

12. IPD Sharing Statement

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Stereotactic Radiation Therapy in Treating Patients With Advanced Liver Cancer

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