Radiosurgery for Glioblastoma Multiforme
Stopped early · Phase 1/Phase 2
Conditions studied: Glioblastoma Multiforme
In brief
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.
Key facts
- Study ID
- NCT00456612
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 4
- Starts
- 2007-02-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2017-03-06
Who can join
Age: 66 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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