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Completed

NCT Number: NCT02092038

Preoperative Chemoradiation for Glioblastoma

Trial to determine the safety of neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tampa General Hospital

Tampa, Florida, 33606, United States

About this study

Prior to any definitive treatment and after enrollment, the patient will undergo stereotactic biopsy of the lesion to confirm the histology of the lesion and to determine methylated methylguanine methyltransferase (MGMT) status. Standard image-guided stereotactic technique will be used. Patients will be treated with conformal radiation therapy. Temozolomide will be given from the day prior to radiation therapy through the last day of radiation therapy. 4-6 weeks after radiation therapy the patient will undergo craniotomy and maximal safe resection. Temozolomide will continue beginning 4 weeks after surgery.

Imaging:

MRI within 2 weeks prior to the start of the protocol. MRI at 4 weeks after chemoradiation therapy and prior to surgery. MRI within 48 hours after surgery.

MRI after every 2 cycles of chemotherapy and then every 2 months until progression, up to 2 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • MRI lesions of the brain that have a high probability of being glioblastoma in a potentially resectable location in the brain (the primary study population)
  • WHO performance status 0-2 (to allow comparison to historical controls)
  • Adequate hematological parameters: (for safety because of neutropenia from the temozolomide)
  • Consent can be obtained from the patient, and if the patient cannot give consent then from the medical power of attorney and if one is not assigned, then the nearest relative (required to obtain consent)
  • Able to have MRI scans (secondary endpoint is MRI scan characteristics)
  • Willing to have radiation treatment at a participating center (homogeneity of treatment parameters)
  • Ages 18-80

Exclusion criteria

  • Unresectable tumor
  • Absolute neutrophil count (ANC) less than 1,200/μL
  • Hemoglobin less than 9.0g/dL
  • Platelet count less than 100,000/μL

Treatment and study plan

Temozolomide

Drug

Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.

Other names: Temodar

partial brain irradiation

Radiation

Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.

stereotactic biopsy of brain tumor

Procedure

will be assessed for tumor type and tumor markers

craniotomy and tumor resection

Procedure

maximal safe resection

Primary outcomes

  1. toxicity of treatment per Common Toxicity Criteria for Adverse Effects V3.0

    Time frame: up to up to 16 weeks

    comparison of toxicity related to experimental treatment to historical local controls

Secondary outcomes

  1. Feasibility of measurement of O(6)-Methylguanine-DNA methyltransferase (MGMT) activity on stereotactic samples

    Time frame: at enrollment

    determination of the feasibility of using standard MGMT activity measurement techniques on stereotactic specimens and comparison of the results with the results from the full resection.

  2. progression free survival

    Time frame: up to 12 months

  3. overall survival

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

Tampa General Hospital

Other

Registry information

Official study title

Phase I Pilot Study of Preoperative Chemoradiation for Glioblastoma

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 19, 2014
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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