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PI/II of Temozolomide & Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Scott Soltys, Stanford University
ClinicalTrials.gov Identifier:
NCT01120639
First received: May 7, 2010
Last updated: January 5, 2017
Last verified: January 2017
  Purpose
The purpose of this study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy with the FDA approved chemotherapy drug temozolomide

Condition Intervention Phase
Glioblastoma Cancer of Brain and Nervous System Glioblastoma Multiforme Drug: Temozolomide Procedure: Stereotactic Radiosurgery Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Temozolomide and Hypofractionated Radiotherapy in Treatment of Supratentorial Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by Scott Soltys, Stanford University:

Primary Outcome Measures:
  • Determine the maximum tolerated dose (MTD) of hypofractionated radiotherapy given in 5 fractions with temozolomide for the treatment of glioblastoma multiforme [ Time Frame: Duration of study ]

Secondary Outcome Measures:
  • Determine the progression-free survival rate. [ Time Frame: Duration of study ]
  • Determine the short- and long-term adverse effects. [ Time Frame: Duration of study ]
  • Determine the radiographic response rate. [ Time Frame: Duration of study ]
  • Determine the overall survival rate. [ Time Frame: Duration of study ]
  • Perform patterns of failure analysis. [ Time Frame: Duration of study ]
  • Assess quality of life during treatment. [ Time Frame: Duration of study ]

Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: November 2020
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTV (Planning Target Volume) < 60 cm3

Hypofractionated stereotactic radiosurgery with concurrent temozolomide

Dose Levels:

  1. 25 Gy in 5 fractions
  2. 30 Gy in 5 fractions
  3. 35 Gy in 5 fractions
  4. 40 Gy in 5 fractions
Drug: Temozolomide
75 mg/m2/day, oral
Other Names:
  • Temodar
  • Temodal
Procedure: Stereotactic Radiosurgery
Standard of care
Other Name: Cyberknife surgery
Experimental: Planning Target Volume of 60 to 150 cm3

Hypofractionated stereotactic radiosurgery with concurrent temozolomide

Dose Levels:

  1. 25 Gy in 5 fractions
  2. 30 Gy in 5 fractions
  3. 35 Gy in 5 fractions
  4. 40 Gy in 5 fractions
Drug: Temozolomide
75 mg/m2/day, oral
Other Names:
  • Temodar
  • Temodal
Procedure: Stereotactic Radiosurgery
Standard of care
Other Name: Cyberknife surgery

Detailed Description:
To determine the maximum tolerated dose (MTD) of hypofractionated (5 fractions) radiotherapy with temozolomide for the treatment of glioblastoma multiforme, patients will be evaluated by a multi-disciplinary team composed of radiation oncologists, neurosurgeons, and neuro-oncologists to assess for their eligibility. Patient's oncologic history, presenting symptoms, physical examination, pathology, and imaging studies will be reviewed. Patients will be evaluated for surgical candidacy and resectability. Patients who are surgical candidates will undergo a surgical resection prior to radiotherapy. Patients whose tumors are unresectable or are not good surgical candidates will undergo a biopsy for tissue diagnosis. Radiation will be delivered in five fractions.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathologically confirmed newly diagnosed glioblastoma multiforme. Diagnosis must be made by surgical biopsy or excision
  • The tumor must be supratentorial in location
  • The planning target volume (tumor plus margin) must measure <= 150 cm^3 in volume
  • Age >=18 years
  • Life expectancy of at least 12 weeks
  • Patient must have adequate organ function to tolerate temozolomide (details in the protocol)

Exclusion Criteria:

  • Patients who have previously been treated with brain irradiation to the region that would result in overlap of the radiation fields
  • Tumor foci detected below the tentorium
  • Multifocal disease or leptomeningeal spread
  • Prior allergic reaction to the study drugs involved in this protocol
  • Patients with pacemaker will be allowed to undergo CT instead of MRI
  • Pediatric patients (age <18), pregnant women, and nursing patients will be excluded
  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: NCT01120639

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Scott Soltys Stanford University
  More Information

Responsible Party: Scott Soltys, Assistant Professor of Radiation Oncology, Stanford University
ClinicalTrials.gov Identifier: NCT01120639     History of Changes
Other Study ID Numbers: BRN0012
SU-04202010-5726 ( Other Identifier: Stanford University )
17774 ( Other Identifier: Stanford IRB )
Study First Received: May 7, 2010
Last Updated: January 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Glioblastoma
Brain Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 18, 2017