A Study Using Radiation Therapy and Temozolomide to Treat Glioblastoma in Patients Over 70
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|ClinicalTrials.gov Identifier: NCT01985087|
Recruitment Status : Recruiting
First Posted : November 15, 2013
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Radiation: Hypofractionated radiotherapy Drug: Temozolomide||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/ II Study of Hypofractionated Radiotherapy With Concurrent Temozolomide Followed by Adjuvant Temozolomide in Patients Over 70 Years Old With Newly Diagnosed Glioblastoma|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||May 2025|
|Estimated Study Completion Date :||May 2025|
Experimental: Hypofractionated radiotherapy and temozolomide
All subjects will receive treatment as is a single arm study. Two weeks of combined hypofractionated radiotherapy with concurrent temozolomide followed by up to 6 cycles of adjuvant temozolomide treatment.
Radiation: Hypofractionated radiotherapy
Treatment of 3.4 Gy will be given daily 5 days per week over 2 weeks.
During concomitant phase Temozolomide will be administered orally at 75 mg/m2 for 2 weeks concomitant with radiotherapy. During the adjuvant phase Temozolomide will be administered orally at 150 mg/m2 on days 1 through day 5 of each 28 day cycle for a maximum of 6 cycles.
Other Name: brand name Temodar
- Number of patients who stop treatment due to CTCAE grade 3 or above toxicities [ Time Frame: 4 weeks after radiation therapy - month 6 ]If < 4 out of 10 patients in the initial analysis stop treatment due to toxicity it can proceed to phase II.
- Overall survival [ Time Frame: from study enrollment to date of death or up to approximately 5 years ]
- Quality of Life [ Time Frame: 7 months after enrollment ]Quality of life will be measured by Fact-BR assessment.
- The number of patients to complete RT+TMZ and a minimum of 3 of the 6 planned cycles of adjuvant chemotherapy [ Time Frame: 7 months after enrollment ]
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): NCT01985087
|United States, Kentucky|
|James Graham Brown Cancer Center||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: Clinical Trials Office 502-562-3429 firstname.lastname@example.org|
|Principal Investigator: Shiao Woo, MD|
|Principal Investigator:||Shiao Woo, MD||James Graham Brown Cancer Center|