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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Treatment Arm :A | Experimental | Patients with a score of Childs A Will receive 3 fractions of radiation over 5-10 days |
|
| Radiation Treatment Arm: B | Experimental | Patients with a score of Childs B will receive 5 fractions of radiation over 2-6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation | Radiation | Arm A: Childs A - receive 3 fractions. Arm B: Childs B - receive 5 fractions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to In-field Failure | Kaplan-Meier Analyses will be used to calculate the median and 95% Confidence Interval for the time until in-field failure. This will be calculated from the time of treatment until the time of in-field failure. If a patient did not have in-field failure, the patient will be censored at their last evaluation date. | up to 4 yrs |
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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:
Adequate renal function (creatinine < 1.8 mg/dl or creatinine clearance ≥ 50 ml/min)
Adequate bone marrow reserve:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Langer, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Department of Radiation Oncology | Indianapolis | Indiana | 46202 | United States |
This is a Phase I/II study. Phase I is a dose finding study, and Phase II will use the doses determined by the Phase I portion to further look at efficacy. During Phase I, it was determined to look at Childs A patients separately from Childs B patients. Patients who were Childs B required a dose reduction during Phase I.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I: 36 Gy | Patients will receive 1200 cGy x 3 fractions of radiation |
| FG001 | Phase I: 42 Gy | Patients will receive 1400 cGy x 3 fractions of radiation |
| FG002 | Phase I: 40 Gy | Patients will receive 800 cGy x 5 fractions of radiation for Childs B only (dose reduction) |
| FG003 | Phase I: 48 Gy | Patients will receive 1600 cGy x 3 fractions of radiation for Childs A only |
| FG004 | Phase II Childs A | Patients in Phase II with a score of Childs A Will receive 3 fractions (48 Gy) of radiation over 5-10 days |
| FG005 | Phase II Childs B | Patients in Phase II with a score of Childs B will receive 5 fractions (40 Gy) of radiation over 2-6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I | Dose escalation to 48 Gy (16Gy/fraction) in Childs A and to 42 Gy (14 Gy/fraction) down to 40 Gy (8Gy/fraction) for Childs B |
| BG001 | Phase II Childs A | Patients in Phase II with a score of Childs A Will receive 3 fractions (48 Gy) of radiation over 5-10 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With DLTs | Number of patients experiencing a Dose Limiting Toxicity during the Phase I portion of the trial. | All patients who received treatment in Phase I | Posted | Count of Participants | Participants | 6 weeks |
|
up to 4 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I: 36 Gy | Patients will receive 1200 cGy x 3 fractions of radiation | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Miller Research Manager | Indiana University | 317 944 1242 | amym@iu.edu |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
| Overall Survival | Kaplan-Meier Analysis will be used to calculate the median and 95% CI for overall survival. This will be calculated from the time of treatment until death. If a patient did not die, the patient will be censored at their last known alive date. | Up to 8 years |
| Phase II: Number of Patients With Treatment Related Grade 3 or 4 Adverse Events | Number of unique patients who had grade 3 or 4 adverse events that were possibly, probably or definitely related to study treatment. | up to 4 years |
| BG002 | Phase II Childs B | Patients in Phase II with a score of Childs B will receive 5 fractions (40 Gy) of radiation over 2-6 weeks. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Patients will receive 800 cGy x 5 fractions of radiation for Childs B only (dose reduction)
| OG003 | Phase I: 48 Gy | Patients will receive 1600 cGy x 3 fractions of radiation for Childs A only |
|
|
| Primary | 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 | All patients who received treatment and had a post-baseline assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
|
| Secondary | Time to In-field Failure | Kaplan-Meier Analyses will be used to calculate the median and 95% Confidence Interval for the time until in-field failure. This will be calculated from the time of treatment until the time of in-field failure. If a patient did not have in-field failure, the patient will be censored at their last evaluation date. | All pts who received treatment and had a post-baseline assessment | Posted | Median | 95% Confidence Interval | months | up to 4 yrs |
|
|
|
| Secondary | Overall Survival | Kaplan-Meier Analysis will be used to calculate the median and 95% CI for overall survival. This will be calculated from the time of treatment until death. If a patient did not die, the patient will be censored at their last known alive date. | all patients who received treatment and had a post-baseline assessment | Posted | Median | 95% Confidence Interval | months | Up to 8 years |
|
|
|
| Secondary | Phase II: Number of Patients With Treatment Related Grade 3 or 4 Adverse Events | Number of unique patients who had grade 3 or 4 adverse events that were possibly, probably or definitely related to study treatment. | All patients who received treatment | Posted | Count of Participants | Participants | up to 4 years |
|
|
|
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | Phase I: 42 Gy | Patients will receive 1400 cGy x 3 fractions of radiation | 4 | 6 | 1 | 6 | 6 | 6 |
| EG002 | Phase I: 40 Gy | Patients will receive 800 cGy x 5 fractions of radiation for Childs B only (dose reduction) | 4 | 5 | 1 | 5 | 5 | 5 |
| EG003 | Phase I: 48 Gy | Patients will receive 1600 cGy x 3 fractions of radiation for Childs A only | 2 | 3 | 1 | 3 | 3 | 3 |
| EG004 | Phase II Childs A | Patients in Phase II with a score of Childs A Will receive 3 fractions (48 Gy) of radiation over 5-10 days | 19 | 39 | 1 | 39 | 39 | 39 |
| EG005 | Phase II Childs B | Patients in Phase II with a score of Childs B will receive 5 fractions (40 Gy) of radiation over 2-6 weeks. | 13 | 21 | 1 | 21 | 21 | 21 |
| potassium | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Leukocytes (total WBC) | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Platelets | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Cardiac arhythmia - other | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Gastrointestinal - other | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| AST, SGOT (serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Bilirubin (hyperbilirubinemia) | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Creatinine | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| GGT (gamma-glutamyl transpeptidase) | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Confusion | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| INR (International Normalized Ratio of Prothrombin time) | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Leukocytes (total WBC) | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Neutrophils/Granulocytes (ANC/AGC) | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Platelets | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| INR (international normalized ratio of prothrobin time) | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| PTT (partial thromboplastin time) | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Ascites (non-malignant) | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Albumin, Serum-low(hypoalbuminemia) | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Alkaline Phosphate | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| ALT, SGPT | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment | Serum Glutamic Pyruvic Transaminase |
|
| AST, SGOT | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment | Serum Glutamic oxaloacetic Transaminase |
|
| Bilirubin | Investigations | MedDRA (12.0) | Non-systematic Assessment | Hyperbilirubinemia |
|
| Calcuim, Serum-Low | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment | hypocalcemia |
|
| Creatinine | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| GGT | Investigations | MedDRA (12.0) | Non-systematic Assessment | Gamma-Glutamyl Transpeptidase |
|
| Potassium | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment | Serum high Hyperkalemia |
|
| Sodium | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment | Serum-low hypokalemia |
|
| Potassium | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment | Serum-Low- Hypokalemia |
|
| Muscle Weakness | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment | Whole body- generalized |
|
| Pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment | Abdomen pain |
|
| Urinary frequency/urgency | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
|
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |