Phase I/II Study of Fractionated CyberKnife Stereotactic Radiosurgery for High Grade Gliomas in Elderly Patients With Poor Performance Status
Inclusion Criteria:
1. Histopathologically confirmed newly diagnosed glioblastoma multiforme or Anaplastic
Glioma (WHO Grade III) by surgical excision or biopsy.
2. Patient must recover from the effects of surgery, post-operative infection, or other
complications.
3. Therapy should start within 5 weeks of surgery
4. Must have an estimated survival of > 8 weeks.
5. KPS < 70.
6. Age > 65 years.
7. Must have a pre- and post operative contrast enhanced MRI scans
8. 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.
-
Exclusion Criteria:
1. Histology grade less than Anaplastic Glioma ( WHO Grade III).
2. Recurrent malignant glioma.
3. Tumor involving the Brain stem.
4. Any detected tumor foci beyond the cranial vault.
5. Major medical or psychiatric illness, which in the investigator's opinion will
prevent administration or completion of the protocol therapy.
6. Prior malignancies, except for non-melanomatous skin cancers, or carcinoma in situ of
uterus, cervix or bladder, unless disease free for > 5 years.
7. Prior chemotherapy for the current disease.
-