Radiosurgery for Glioblastoma Multiforme
| Status: | Terminated |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 66 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2007 |
| End Date: | December 2010 |
Phase I/II Study of Fractionated CyberKnife Stereotactic Radiosurgery for High Grade Gliomas in Elderly Patients With Poor Performance Status
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.
(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.
(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.
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 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.
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