Dose Escalation Study for Primary Hepatocellular Carcinoma

NCT ID: NCT00243841

Last Updated: 2018-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2016-12-31

Brief Summary

The purpose of this study is to determine the maximum tolerated dose of limited fractions of large dose radiation in an effort to achieve a biologically potent cancer therapy in selected patients with primary hepatocellular carcinoma.

Detailed Description

Despite recent advances in early detection and diagnosis, only 30-40% of patients with hepatocellular carcinoma may benefit from radical therapies. Liver transplantation offers the best chance for cure. Surgical resection has been the only other potentially curative option, but the majority of patients are not candidates for resection. This reflects the usual comorbidity of severe underlying liver disease that either precludes surgery or makes the surgical approach extremely dangerous.

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiation Treatment Arm :A

Patients with a score of Childs A Will receive 3 fractions of radiation over 5-10 days

Group Type: EXPERIMENTAL

Stereotactic Body Radiation

Intervention Type: RADIATION

Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.

Radiation Treatment Arm: B

Patients with a score of Childs B will receive 5 fractions of radiation over 2-6 weeks.

Group Type: EXPERIMENTAL

Stereotactic Body Radiation

Intervention Type: RADIATION

Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.

Interventions

Stereotactic Body Radiation

Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.

Intervention Type: RADIATION

Other Intervention Names

Stereotactic Body Radiation Treatments

Eligibility Criteria

Inclusion Criteria

Evaluation by the Surgery and/or Liver Transplant Team has been performed and the patient is not considered a candidate for either "standard" therapy to target area (upper abdomen)

• Adequate liver function defined as:

• total bilirubin < 3mg/dl, albumin > 2.5 g/dl
• normal PT/PTT unless on anticoagulants
• mild elevation of liver enzymes acceptable (must be less than three times upper limit of normal)
• Adequate renal function (creatinine < 1.8 mg/dl or creatinine clearance ≥ 50 ml/min)
• Adequate bone marrow reserve:

• ANC count ≥ 1500 mm3
• Platelets ≥ 50,000/mm3
• Hemoglobin > 9 g/dL

NOTE: Lab values must be obtained within 2 weeks prior to being registered for protocol therapy.

Exclusion Criteria

• No history of systemic lupus erythematous, rheumatoid arthritis, systemic sclerosis or scleroderma
• No chemotherapy within 14 days before radiotherapy (chemotherapy may cause transient hepatitis with hepatomegaly)
• No subsequent chemotherapy planned within 2 weeks of radiotherapy
• No active liver infection
• No acute Hepatitis. Definition of active disease:

• Hepatitis A: Acute hepatitis determined by presence of Anti-HAV- IgM
• Hepatitis B:

1. HBsAg (HB surface Antigen): present in patients with acute and chronic hepatitis

2. HBV DNA present in patients with active viral replication in amounts greater than 100,000 copies

3. HBeAg is present in wild type HBV infection and suggests active replication

4. Anti-HBs: Antibody against HBsAg appears after HBV infections and confers immunity

5. Anti-HBc-IgM: Antibody against HBcAg, fraction IgM, present in acute infection and often could be detected during periods of high viral replication in chronic disease

6. Anti-HBc-IgG: is present in chronic disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Indiana University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Mark Langer

Professor of Clinical Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Langer, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University Department of Radiation Oncology

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

0404-20 (1011003002)

Identifier Type: -

Identifier Source: org_study_id