NCT00456612

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

October 5, 2015

Completed
Last Updated

March 6, 2017

Status Verified

January 1, 2017

Enrollment Period

3.8 years

First QC Date

April 4, 2007

Results QC Date

June 22, 2011

Last Update Submit

January 23, 2017

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (2)

  • The Percent Progression -Free Survival at 6 Months Will be Tabulated

    6 months

  • Progression Free Survival

    consent to prgression or death

Secondary Outcomes (1)

  • Response, Median Time to Tumor Progression,Overall Survival, Percent Overall Survival at 1 Year Will be Tabulated.

    1year

Study Arms (1)

Cyberknife

OTHER

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

Procedure: CyberKnife

Interventions

CyberKnifePROCEDURE

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

Cyberknife

Eligibility Criteria

Age66 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Histopathologically confirmed newly diagnosed glioblastoma multiforme or Anaplastic Glioma (WHO Grade III) by surgical excision or biopsy.
  • Patient must recover from the effects of surgery, post-operative infection, or other complications.
  • Therapy should start within 5 weeks of surgery
  • Must have an estimated survival of \> 8 weeks.
  • KPS \< 70.
  • Age \> 65 years.
  • Must have a pre- and post operative contrast enhanced MRI scans
  • 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.

You may not qualify if:

  • Histology grade less than Anaplastic Glioma ( WHO Grade III).
  • Recurrent malignant glioma.
  • Tumor involving the Brain stem.
  • Any detected tumor foci beyond the cranial vault.
  • Major medical or psychiatric illness, which in the investigator's opinion will prevent administration or completion of the protocol therapy.
  • Prior malignancies, except for non-melanomatous skin cancers, or carcinoma in situ of uterus, cervix or bladder, unless disease free for \> 5 years.
  • Prior chemotherapy for the current disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Limitations and Caveats

Early termination due to difficulty in recruitment and retaining due to extremely bad prognosis of disease

Results Point of Contact

Title
Anand Mahadevan, MD
Organization
Beth Israel Deaconess Medical Center
amahadev@bidmc.harvard.edu
617-667-2345

Study Officials

  • Anand Mahadevan, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncologist

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 5, 2007

Study Start

February 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 6, 2017

Results First Posted

October 5, 2015

Record last verified: 2017-01

Locations

US(1)