Radiosurgery for Glioblastoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00456612
First received: April 4, 2007
Last updated: February 3, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Glioblastoma Multiforme
Procedure: CyberKnife
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • The percent progression -free survival at 6 months will be tabulated [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response, median time to tumor progression,overall survival, percent overall survival at 1 year will be tabulated. [ Time Frame: 1year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: CyberKnife
    Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.
    Other Name: Cyberknife
  Eligibility

Ages Eligible for Study:   66 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456612

Contacts
Contact: Anand Mahadevan, MD 617-667-2345 amahadev@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Anand Mahadevan, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Anand Mahadevan, BIDMC
ClinicalTrials.gov Identifier: NCT00456612     History of Changes
Other Study ID Numbers: 2006P-000464
Study First Received: April 4, 2007
Last Updated: February 3, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on October 16, 2014