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This clinical trial is a prospective study of radiosurgery treatment for progressive GBM to test 1)the efficacy of radiosurgery for recurrent/progressive GBM compared to chemotherapy , and 2) the role of diffusion-weighted image (DWI) to predict the early tumor progression and treatment response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractionated Radiosurgery and Bevacizumab | Experimental | FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression |
|
| Bev with Chemo | Active Comparator | Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug |
| ||
| Chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Local Tumor Control | 2 months | |
| Overall Survival | 12 months | |
| Progression Free Survival | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
• Warfarin or LMW heparin patients must have no active bleeding or pathological condition that carries a high risk of bleeding
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| Name | Affiliation | Role |
|---|---|---|
| Farzan Siddiqui, MD | Henry Ford Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fractionated Radiosurgery and Bevacizumab | FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression Bevacizumab Chemotherapy Fractionated radiosurgery |
| FG001 | Bev With Chemo | Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression Bevacizumab Chemotherapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fractionated Radiosurgery and Bevacizumab | FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression Bevacizumab Chemotherapy Fractionated radiosurgery |
| BG001 | Bev With Chemo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Local Tumor Control | Posted | Count of Participants | Participants | 2 months |
|
|
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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 | Fractionated Radiosurgery and Bevacizumab | FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression Bevacizumab Chemotherapy Fractionated radiosurgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Grade 3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marissa Gilbert | Henry Ford Health System | 313-556-8422 | mgilber6@hfhs.org |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001254 | Astrocytoma |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D004358 | Drug Therapy |
| D000077204 | Temozolomide |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
|
|
| Fractionated radiosurgery | Radiation |
|
Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression Bevacizumab Chemotherapy |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Diagnosis | Count of Participants | Participants |
|
| Neoadjuvant RT Dose | Count of Participants | Participants |
|
| Neoadjuvant Chemotherapy | Count of Participants | Participants |
|
| On-Trial Chemotherapy | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Overall Survival | Posted | Median | 95% Confidence Interval | months | 12 months |
|
|
|
|
| Primary | Progression Free Survival | Posted | Median | 95% Confidence Interval | months | 12 months |
|
|
|
|
| 15 |
| 18 |
| 5 |
| 18 |
| 0 |
| 18 |
| EG001 | Bev With Chemo | Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression Bevacizumab Chemotherapy | 14 | 17 | 4 | 17 | 0 | 17 |
|
| Headache | Nervous system disorders | Systematic Assessment | Grade 3 |
|
| Nausea/Vomiting | General disorders | Systematic Assessment | Grade 3 |
|
| New Onset Weakness | General disorders | Systematic Assessment | Grade 3 |
|
| Seizure | Nervous system disorders | Systematic Assessment | Grade 3 |
|
| Cerebral Edema | Nervous system disorders | Systematic Assessment | Grade 3 |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment | Grade 3 |
|
| Altered Mental Status | Nervous system disorders | Systematic Assessment | Grade 3 |
|
| Intratumoral Hemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Grade 3 |
|
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| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| BEV+irinotecan |
|
| BEV+temozolomide |
|
| No trial chemotherapy |
|