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Poor accrual
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Conventional radiation for 6 weeks is not well tolerated by the elderly. Shorter courses (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly- particularly in patients who are generally in poor performance status (KPS<70). Fractionated Cyberknife Radiosurgery can deliver equivalent doses in 5 treatments providing the same tumor control in a much shorter and tolerable schedule improving their quality of their short life.
To assess the tolerability of Cyberknife Radiosurgery for High Grade Gliomas in Elderly with poor performance status.
Secondary:
Assessment of local control rate, progression free survival, overall survival, quality of life and toxicity and steroid dependence in this population with this regime.
Conventional radiation for 6 weeks is not well tolerated by the elderly. Shorter courses (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly- particularly in patients who are generally in poor performance status (KPS<70). Fractionated Cyberknife Radiosurgery can deliver equivalent doses in 5 treatments providing the same tumor control in a much shorter and tolerable schedule improving their quality of their short life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyberknife | Other | Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CyberKnife | Procedure | Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percent Progression -Free Survival at 6 Months Will be Tabulated | 6 months | |
| Progression Free Survival | consent to prgression or death |
| Measure | Description | Time Frame |
|---|---|---|
| Response, Median Time to Tumor Progression,Overall Survival, Percent Overall Survival at 1 Year Will be Tabulated. | 1year |
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Inclusion Criteria:
Histopathologically confirmed newly diagnosed glioblastoma multiforme or Anaplastic Glioma (WHO Grade III) by surgical excision or biopsy.
Patient must recover from the effects of surgery, post-operative infection, or other complications.
Therapy should start within 5 weeks of surgery
Must have an estimated survival of > 8 weeks.
KPS < 70.
Age > 65 years.
Must have a pre- and post operative contrast enhanced MRI scans
Laboratory values within the following limits: ANC (absolute neutrophil count) >/= 1500 cell/ul Platelets >/= 100x 10(3)/ul, Hemoglobin >/= 9g/dl, Serum Creatinine ≤ 1.5mg/dl., Serum total Bilirubin </= 1.5 x upper limit of normal (ULN), SGOT/SGPT </= 2.5x ULN, Albumin >/= 3g/dl.
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Exclusion Criteria:
Histology grade less than Anaplastic Glioma ( WHO Grade III).
Recurrent malignant glioma.
Tumor involving the Brain stem.
Any detected tumor foci beyond the cranial vault.
Major medical or psychiatric illness, which in the investigator's opinion will prevent administration or completion of the protocol therapy.
Prior malignancies, except for non-melanomatous skin cancers, or carcinoma in situ of uterus, cervix or bladder, unless disease free for > 5 years.
Prior chemotherapy for the current disease.
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| Name | Affiliation | Role |
|---|---|---|
| Anand Mahadevan, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cyberknife | Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Single arm Phase II Study |
| 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 | The Percent Progression -Free Survival at 6 Months Will be Tabulated | Posted | 6 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 | Single Arm Study | Single arm Phase II Study |
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Early termination due to difficulty in recruitment and retaining due to extremely bad prognosis of disease
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anand Mahadevan, MD | Beth Israel Deaconess Medical Center | 617-667-2345 | amahadev@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Secondary | Response, Median Time to Tumor Progression,Overall Survival, Percent Overall Survival at 1 Year Will be Tabulated. | Not Posted | 1year | Participants |
| Primary | Progression Free Survival | Posted | consent to prgression or death |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
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| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |