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Radiosurgery for Glioblastoma Multiforme

This study has been terminated.
(Poor accrual)
Sponsor:
Information provided by (Responsible Party):
Anand Mahadevan, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00456612
First received: April 4, 2007
Last updated: December 18, 2015
Last verified: December 2015
  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: 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 ]
  • Progression Free Survival [ Time Frame: consent to prgression or death ] [ 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 ]

Enrollment: 4
Study Start Date: February 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   66 Years and older   (Senior)
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

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
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

Responsible Party: Anand Mahadevan, Radiation Oncologist, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00456612     History of Changes
Other Study ID Numbers: 2006P-000464 
Study First Received: April 4, 2007
Results First Received: June 22, 2011
Last Updated: December 18, 2015
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 December 08, 2016