Dose Escalation Study for Primary Hepatocellular Carcinoma

NCT00243841 | Completed Results DMC

• 1 other identifier: 0404-20 (1011003002)
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (2)

• Number of Patients With DLTs

  Number of patients experiencing a Dose Limiting Toxicity during the Phase I portion of the trial.

  6 weeks

• 6 Month Local In-field Control

  Percent of patients and the 95% Binomial Confidence interval who were free of in-field progression at 6 months following treatment for the patients in Phase II

  6 months

Secondary Outcomes (3)

• Time to In-field Failure

  up to 4 yrs

• Overall Survival

  Up to 8 years

• Phase II: Number of Patients With Treatment Related Grade 3 or 4 Adverse Events

  up to 4 years

Study Arms (2)

Radiation Treatment Arm :A

EXPERIMENTAL

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

Radiation: Stereotactic Body Radiation

Radiation Treatment Arm: B

EXPERIMENTAL

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

Radiation: Stereotactic Body Radiation

Interventions

Stereotactic Body Radiation RADIATION

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

Also known as: Stereotactic Body Radiation Treatments

Radiation Treatment Arm :A; Radiation Treatment Arm: B

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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:
• HBsAg (HB surface Antigen): present in patients with acute and chronic hepatitis
• HBV DNA present in patients with active viral replication in amounts greater than 100,000 copies
• HBeAg is present in wild type HBV infection and suggests active replication
• Anti-HBs: Antibody against HBsAg appears after HBV infections and confers immunity
• 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
• Anti-HBc-IgG: is present in chronic disease

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Indiana University Department of Radiation Oncology

Indianapolis, Indiana, 46202, United States

Location

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

Results Point of Contact

• Title: Amy Miller Research Manager
• Organization: Indiana University

amym@iu.edu

317 944 1242

Study Officials

• Mark Langer, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Radiation Oncology

Study Record Dates

• First Submitted: October 21, 2005
• First Posted: October 25, 2005
• Study Start: May 1, 2004
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: December 13, 2018
• Results First Posted: December 13, 2018

Record last verified: 2018-11

Locations

US (1)