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Phase II Trial of Low-Dose Whole Brain Radiotherapy With Concurrent Temozolomide and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma Multiforme

NCT01822275 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-12-29

Study results available
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Summary

In the current proposed trial the role of the low-dose WBRT (0.15 Gy) would be to safely treat the microscopic distant GBM cells outside of the high dose RT region and sensitize the gross tumor, while the focal radiation dose (1.85 Gy) to the gross tumor will bring the total tumor dose of 2 Gy per fraction which is the standard of care.

Radiotherapy (RT) has been integral in the treatment of GBM since the 1970s when Walker et al. showed that post-operative whole brain radiotherapy (WBRT) offered significant improvements in median survival time, and even more so when given with concomitant BCNU chemotherapy. Ensuing dose escalation studies found the optimal dose to be 60 Gy. Patients could not tolerate escalation to higher doses than 60 Gy with WBRT due to unacceptable toxicity. Even with WBRT of 60 Gy, a huge volume of healthy brain tissue was unnecessarily treated with high-dose radiation; recurrences with WBRT remained overwhelmingly local. Hochberg and Pruitt (1980) found that after WBRT only 3% of recurrences were outside 2 cm of the margins of the primary tumor. With the rise of the CT scan in the 1980s and the MRI in the 1990s, along with subsequent improvements in three-dimensional conformal radiation, partial brain RT (PBRT) became practical since tumor margins could be visualized and irradiated more accurately. - Subsequently, WBRT was shown to provide no survival benefit over PBRT at the same dosage; - thus, the latter took over as the standard of care.

Conditions

  • Histologically Proven Diagnosis of Glioblastoma or Gliosarcoma (WHO Grade IV)

Interventions

DRUG

Chemotherapy with Temodar.

Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by a maximum of 12 cycles of adjuvent chemotherapy with Temodar.

RADIATION

Radiation therapy

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Young Kwok, MD · University of Maryland, Baltimore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01822275 on ClinicalTrials.gov