Status:
COMPLETED
Short Course of Radiation for Gliomas in Elderly Patients
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
High Grade Gliomas
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
Patients with high grade brain tumors will be treated to test shortened course of radiation therapy with the use of precise, focused radiation with cyberknife.
Detailed Description
Screening Procedures: Screening procedures are tests and procedures that will be done to determine if you are eligible to take part in the research study. For this research study, the screening proced...
Eligibility Criteria
Inclusion
- Histologically confirmed High Grade Glioma (oligo-, astro- or mixed gliomas).
- \>65 years of age
- KPS\>70
- No contraindication for Radiation or Chemotherapy
- Histopathologically confirmed newly diagnosed glioblastoma multiforme or Anaplastic Glioma (WHO Grade III) by surgical excision or biopsy.
- Patient must have recovered 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) \>/= 1.5x 109/l, Platelets \>/= 100x 10 9 /L, 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.
- If the patient receiving an enzyme inducing antiepileptic drug will be switched to an NEIAED (Non Enzyme Inducing Anti Epileptic Drug).
Exclusion
- 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 radiation to the head or neck (except for T1 glottic cancer) resulting in overlap of radiation fields.
- Prior chemotherapy for the current disease.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00386919
Start Date
April 1 2006
End Date
December 1 2013
Last Update
January 27 2017
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215