Radiosurgery for Glioblastoma Multiforme

NCT ID: NCT00456612

Last Updated: 2017-03-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2010-12-31

Brief Summary

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.

Detailed 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.

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cyberknife

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

Group Type: OTHER

CyberKnife

Intervention Type: PROCEDURE

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

Interventions

CyberKnife

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

Intervention Type: PROCEDURE

Eligibility 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.

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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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• Minimum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Anand Mahadevan

Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anand Mahadevan, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2006P-000464

Identifier Type: -

Identifier Source: org_study_id