Radiosurgery for Glioblastoma Multiforme

Glioblastoma Multiforme Clinical Trial

Official title:

Phase I/II Study of Fractionated CyberKnife Stereotactic Radiosurgery for High Grade Gliomas in Elderly Patients With Poor Performance Status

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00456612
• Other study ID #: 2006P-000464
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: April 4, 2007
• Last updated: December 18, 2015
• Start date: February 2007
• Est. completion date: December 2010

Study information

• Verified date: December 2015
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 66 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Procedure:
• CyberKnife
Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percent Progression -Free Survival at 6 Months Will be Tabulated		6 months	No
Primary	Progression Free Survival		consent to prgression or death	No
Secondary	Response, Median Time to Tumor Progression,Overall Survival, Percent Overall Survival at 1 Year Will be Tabulated.		1year	No