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Radiosurgery for Glioblastoma Multiforme

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ClinicalTrials.gov Identifier: NCT00456612
Recruitment Status : Terminated (Poor accrual)
First Posted : April 5, 2007
Results First Posted : October 5, 2015
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Anand Mahadevan, Beth Israel Deaconess Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Procedure: CyberKnife Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Fractionated CyberKnife Stereotactic Radiosurgery for High Grade Gliomas in Elderly Patients With Poor Performance Status
Study Start Date : February 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Cyberknife
Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.
 Procedure: CyberKnife
Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.


Outcome Measures
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Primary Outcome Measures :
  1. The Percent Progression -Free Survival at 6 Months Will be Tabulated [ Time Frame: 6 months ]
  2. Progression Free Survival [ Time Frame: consent to prgression or death ]

Secondary Outcome Measures :
  1. Response, Median Time to Tumor Progression,Overall Survival, Percent Overall Survival at 1 Year Will be Tabulated. [ Time Frame: 1year ]

Eligibility Criteria
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Ages Eligible for Study:   66 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

    -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456612


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Anand Mahadevan, MD Beth Israel Deaconess Medical Center
More Information
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Responsible Party: Anand Mahadevan, Radiation Oncologist, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00456612    
Other Study ID Numbers: 2006P-000464
First Posted: April 5, 2007    Key Record Dates
Results First Posted: October 5, 2015
Last Update Posted: March 6, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue