Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

• Sponsor: Albert Einstein College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01899261
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 102.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This pilot clinical trial studies stereotactic body radiation therapy in treating patients with liver cancer that cannot be removed by surgery. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Condition or Disease	Intervention/Treatment	Phase
Adult Hepatocellular Carcinoma; Advanced Adult Hepatocellular Carcinoma; Localized Non-Resectable Adult Liver Carcinoma; Recurrent Adult Liver Carcinoma	Radiation: Stereotactic Radiosurgery	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. To evaluate feasibility and safety of stereotactic body radiation therapy (SBRT) of the liver for treatment of hepatocellular carcinoma (HCC).

SECONDARY OBJECTIVES:

1. To evaluate radiographic local response, local control and time to local progression (TTLP) of treated lesions in HCC patients after liver SBRT.

2. To evaluate overall survival (OS) and cancer specific survival (CSS) in HCC patients treated with liver SBRT.

3. To evaluate explanted irradiated liver tissue (for patients who proceed to liver transplantation) to determine extent of residual tumor and extent of radiation effects within and around the irradiated field.

OUTLINE:

Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months and then every 6 months for up to 2 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Stereotactic Liver Irradiation for Hepatocellular Carcinoma
• Actual Study Start Date: Oct 7, 2010
• Actual Primary Completion Date: May 9, 2016
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (SBRT) Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.	Radiation: Stereotactic Radiosurgery; Undergo SBRT; Other Names: Stereotactic External Beam Irradiation stereotactic external-beam radiation therapy Stereotactic Radiation Therapy Stereotactic Radiotherapy stereotaxic radiation therapy stereotaxic radiosurgery

Outcome Measures

Primary Outcome Measures

1. Severe Treatment-related Toxicity [Within 3 months of SBRT]

   The percentage of patients who have severe treatment-related toxicity will be computed, along with exact 95% confidence intervals. Severe toxicity will be defined as grade 4 or 5 hepatic toxicity, thrombocytopenia, or gastrointestinal toxicity, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

Secondary Outcome Measures

1. CSS [Time from study entry to death from HCC progression, assessed up to 2 years]

   Competing risk analysis will be performed.

2. OS [Time from study entry to death from any cause, assessed up to 2 years]

   Estimated by the Kaplan-Meier method.

3. Response Rate Defined as Proportion of Patients Achieving a Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) [Up to 6 months after completion of SBRT]

4. TTLP [Time from study entry to radiographic local progression based on RECIST, assessed up to 2 years]

   Estimated by the Kaplan-Meier method.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Life expectancy > 3 months

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2

• HCC diagnosed by either of the following approaches:

• Histologic confirmation of HCC on biopsy

• Evidence of vascular enhancement of suspected lesion on at least two imaging techniques

• Evidence of vascular enhancement on a single technique if the alpha-fetoprotein (AFP) is > 200 ng/mL in the setting of cirrhosis or chronic hepatitis B/C

• HCC must be deemed unresectable by an experienced surgeon or patient must be medically inoperable or extra-hepatic metastases must be present (making resection an inappropriate treatment option) or patient must have declined the option of surgery after consultation with a surgeon

• Barcelona Clinic Liver Cancer score of B or C required (i.e., intermediate or advanced stage HCC)

• Prior liver resection or ablative therapy is permitted

• Prior transarterial chemoembolization (TACE) is permitted

• Patients must have recovered from the effects of previous therapy

• Maximal tumor size of 15 cm and > 700 cc of uninvolved liver

• Hemoglobin > 9.0 g/L

• Absolute neutrophil count >= 1.0 bil/L

• Platelets >= 70,000 bil/L

• Total bilirubin < 2 mg/dL

• International normalized ratio (INR) =< 1.5 or correctable with vitamin K (higher INR acceptable if patient is on Coumadin)

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 6 times upper range of normal

Exclusion Criteria:

• Active hepatitis or encephalopathy related to liver failure

• Prior radiation therapy to the upper abdomen or thorax

• Lesions within 1 cm from the stomach

• Prior uncontrolled, life threatening malignancy within the previous 6 months

• Pregnancy is not permitted; women of child-bearing age must undergo pregnancy testing prior to enrollment

• Previous gastric, duodenal or variceal bleed within the past 2 months

• Thrombolytic therapy within 4 weeks or commencement of anticoagulant use within the past 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Albert Einstein College of Medicine	Bronx	New York	United States	10461

Sponsors and Collaborators

• Albert Einstein College of Medicine
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Nitin Ohri, Albert Einstein College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nitin Ohri, Principal Investigator, Albert Einstein College of Medicine
• ClinicalTrials.gov Identifier: NCT01899261
• Other Study ID Numbers: 2010-326; 2010-326; P30CA013330
• First Posted: Jul 15, 2013
• Last Update Posted: Dec 8, 2021
• Last Verified: Dec 1, 2021

• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms

Study Results

Participant Flow

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity. Stereotactic Radiosurgery: Undergo SBRT
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity. Stereotactic Radiosurgery: Undergo SBRT
Overall Participants	20
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	67
Sex: Female, Male (Count of Participants)
Female	6 30%
Male	14 70%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 40%
Not Hispanic or Latino	11 55%
Unknown or Not Reported	1 5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 20%
White	6 30%
More than one race	5 25%
Unknown or Not Reported	5 25%
Region of Enrollment (participants) [Number]
United States	20 100%
Child-Pugh Score (Count of Participants)
5	10 50%
6	7 35%
7	3 15%

Outcome Measures

1. Primary Outcome

Title	Severe Treatment-related Toxicity
Description	The percentage of patients who have severe treatment-related toxicity will be computed, along with exact 95% confidence intervals. Severe toxicity will be defined as grade 4 or 5 hepatic toxicity, thrombocytopenia, or gastrointestinal toxicity, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Time Frame	Within 3 months of SBRT

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity. Stereotactic Radiosurgery: Undergo SBRT
Measure Participants	20
Count of Participants [Participants]	0 0%

2. Secondary Outcome

Title	CSS
Description	Competing risk analysis will be performed.
Time Frame	Time from study entry to death from HCC progression, assessed up to 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	OS
Description	Estimated by the Kaplan-Meier method.
Time Frame	Time from study entry to death from any cause, assessed up to 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Response Rate Defined as Proportion of Patients Achieving a Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame	Up to 6 months after completion of SBRT

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	TTLP
Description	Estimated by the Kaplan-Meier method.
Time Frame	Time from study entry to radiographic local progression based on RECIST, assessed up to 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity. Stereotactic Radiosurgery: Undergo SBRT
All Cause Mortality
	Treatment (SBRT)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment (SBRT)
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Treatment (SBRT)
	Affected / at Risk (%)	# Events
Total	8/20 (40%)
Blood and lymphatic system disorders
Thrombocytopenia	2/20 (10%)	2
Gastrointestinal disorders
Nausea	2/20 (10%)	2
Abdominal pain	1/20 (5%)	1
General disorders
Fatigue	3/20 (15%)	3
Skin and subcutaneous tissue disorders
Dermatitis	1/20 (5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.