Phase II Trial of Low-Dose Whole Brain Radiotherapy With Concurrent Temozolomide and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma Multiforme (GCC 1224)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01822275|
Recruitment Status : Recruiting
First Posted : April 2, 2013
Last Update Posted : July 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Histologically Proven Diagnosis of Glioblastoma or Gliosarcoma (WHO Grade IV)||Drug: Chemotherapy with Temodar. Radiation: Radiation therapy||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Low-Dose Whole Brain Radiotherapy With Concurrent Temozolomide and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma Multiforme|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Low Dose WBRT
Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by either 6 or a maximum of 12 cycles of adjuvent chemotherapy with Temodar.
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
- Efficacy of low-dose whole brain RT (WBRT)in patients with GBM [ Time Frame: 2017 ]To determine the safety and efficacy of low-dose whole brain RT (WBRT) when given concurrently to the standard TMZ and focal partial brain RT (efficacy will be measured by decreased distant disease recurrence rate).
- Radiographic (CT-MRI) response assesment and treatment failure patterns of patients with GBM [ Time Frame: 2017 ]To determine the radiographic response with the combination therapy. To determine the treatment failure patterns after the combination therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822275
|Contact: Caroline Poff, RNfirstname.lastname@example.org|
|United States, Maryland|
|Baltimore, Maryland, United States, 21201|
|Contact: Caroline Poff, RN 410-369-5264 email@example.com|
|Principal Investigator:||Young Kwok, MD||University of Maryland|