Phase I/II Study of Fractionated CyberKnife Stereotactic Radiosurgery for High Grade Gliomas in Elderly Patients With Poor Performance Status
CyberKnife
Astrocytoma+7
+ Glioblastoma
+ Glioma
Treatment Study
Summary
Study start date: February 1, 2007
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.4 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 66 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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. \-
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Beth Israel Deaconess Medical Center
Boston, United StatesOpen Beth Israel Deaconess Medical Center in Google Maps