Short Course of Radiation for Gliomas in Elderly Patients

Completed · Phase 2

Conditions studied: High Grade Gliomas

In brief

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.

Key facts

Study ID

NCT00386919

Run by

Beth Israel Deaconess Medical Center

People needed

26

Starts

2006-04-01

Expected to finish

2013-12-01

Last updated by the study team

2017-01-27

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

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 radiation to the head or neck (except for T1 glottic cancer) resulting in overlap of radiation fields.
• 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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