Short Course of Radiation for Gliomas in Elderly Patients

NCT00386919 | Completed Phase 2

• 1 other identifier: 2006P-000110/3
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with high grade brain tumors will be treated to test shortened course of radiation therapy with the use of precise, focused radiation with cyberknife.

Conditions

High Grade Gliomas

Outcome Measures

Primary Outcomes (1)

• To assess the tolerability of short duration involved field radiation followed by CyberKnife Radiosurgery Boost

  1 month

Secondary Outcomes (1)

• Assessment of local control rate, progression free survival, overall survival, quality of life and toxicity and steroid dependence in this population with this regime

  6 months

Interventions

CyberKnife PROCEDURE

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Histologically confirmed High Grade Glioma (oligo-, astro- or mixed gliomas).
• \>65 years of age
• KPS\>70
• No contraindication for Radiation or Chemotherapy
• Histopathologically confirmed newly diagnosed glioblastoma multiforme or Anaplastic Glioma (WHO Grade III) by surgical excision or biopsy.
• Patient must have recovered 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) \>/= 1.5x 109/l, Platelets \>/= 100x 10 9 /L, 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.
• If the patient receiving an enzyme inducing antiepileptic drug will be switched to an NEIAED (Non Enzyme Inducing Anti Epileptic Drug).

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 radiation to the head or neck (except for T1 glottic cancer) resulting in overlap of radiation fields.
• Prior chemotherapy for the current disease.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anand Mahadevan, MD

  Beth Israel Deaconess Medical Center, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: October 11, 2006
• First Posted: October 12, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

US (1)