Radiosurgery for Glioblastoma Multiforme

Beth Israel Lahey Health

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Glioblastoma Multiforme

Treatments: Procedure: CyberKnife

Study type: Interventional

Funder types: Other

Identifiers

NCT00456612

2006P-000464

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4 patients

Sex: All

Ages: 66+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Cyberknife

Other group

Description:

Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.

Treatment:

Procedure: CyberKnife