Dose Escalation Study for Primary Hepatocellular Carcinoma (SBF-HCC)
This study is currently recruiting participants.
Verified April 2012 by Indiana University
Sponsor:
Indiana University School of Medicine
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00243841
First received: October 21, 2005
Last updated: April 5, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Hepatocellular |
Radiation: Stereotactic Body Radiation |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multi-institution Phase I/II Dose Escalation Study of Hypofractionated Stereotactic Body Radiation Therapy for Primary Hepatocellular Carcinoma |
Further study details as provided by Indiana University:
Primary Outcome Measures:
- To determine 6 month local in-field control of this patient population [ Time Frame: 2 years from enrollment completion ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the in-field treatment response and failure rate of this therapy [ Time Frame: Post Treatment ] [ Designated as safety issue: Yes ]
- To evaluate the dose limiting toxicity (DLT) of this therapy [ Time Frame: Lifetime ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2004 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Radiation Treatment Arm :A
Patients with a score of Childs A Will receive 3 fraction of radiation over 5-10 days
|
Radiation: Stereotactic Body Radiation
Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.
Other Name: Stereotactic Body Radiation Treatments
|
|
Radiation Treatment Arm: B
Patients with a score of Childs B will receive 5 fractions of radiation over 2-6 weeks.
|
Radiation: Stereotactic Body Radiation
Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions.
Other Name: Stereotactic Body Radiation Treatments
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243841
Contacts
| Contact: Higinia Cardenes, MD PhD | 317-944-2525 | hcardene@iupui.edu |
| Contact: Jill DeLuca, CCRp | 317-944-1189 ext j | jdelucca@iupui.edu |
Locations
| United States, Indiana | |
| Indiana University Department of Radiation Oncology | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Higinia Cardenes, MD PhD 317-944-2525 hcardene@iupui.edu | |
| Principal Investigator: Higinia Cardenes, MD PhD | |
Sponsors and Collaborators
Indiana University School of Medicine
University of Colorado, Denver
Investigators
| Principal Investigator: | Higinia Cardenes | Indiana University School of Medicine |
More Information
No publications provided
| Responsible Party: | Indiana University ( Indiana University School of Medicine ) |
| ClinicalTrials.gov Identifier: | NCT00243841 History of Changes |
| Other Study ID Numbers: | 0404-20 |
| Study First Received: | October 21, 2005 |
| Last Updated: | April 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 23, 2013