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| Name | Class |
|---|---|
| James Graham Brown Cancer Center | OTHER |
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In this study we propose to determine outcomes of patients age 70 or older treated with radiation over 2 weeks given with temozolomide 75 mg/m2 daily during radiotherapy and as a post radiation treatment of 150 mg/m2 - 200 mg /m2 for 6 cycles or until the disease progresses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated radiotherapy and temozolomide | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated radiotherapy | Radiation | Treatment of 3.4 Gy will be given daily 5 days per week over 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who stop treatment due to Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or above toxicities.. | If < 4 out of 10 patients in the initial analysis stop treatment due to toxicity it can proceed to phase II. | baseline, 14-28 days post-surgery, 4 weeks post chemo-radiation therapy, 1, 2, 3, 4, 5, and 6 months post Radiation Therapy |
| Overall survival | Survival status will be collected after completion of chemo-radiation at minimum every 3 months for up to 12 months, then every 6 months until date of death. | From date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, PI decision) or death from any cause, whichever is first, assessed up to 100 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate progression-free survival (PFS) | Survival/Documentation of progressive disease status will be collected every 3 months post chemo-radiation up to 12 months, then every 6 months until death, or from the date of disease progression, the date of study discontinuation (e.g. toxicity, PI decision), or from the date of the last dose of study drug (concomitant or adjuvant) if no disease progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Explore association of Overall Survival (OS) and Progression Free Survival (PFS) with 06-methylguanine-DNA methyltransferase gene (MGMT) methylation status | Survival/Documentation of progressive disease status will be collected 4-weeks post chemo-radiation therapy then every 3 months up to 12 months, then every 6 months until death, from either the date of disease progression, the date of study discontinuation (e.g. toxicity, PI decision), or from the date of the last dose of study drug (concomitant or adjuvant) if no disease progression. |
Inclusion Criteria:
Participants must have histologically confirmed glioblastoma/gliosarcoma.
Tumor o6-methylguanine-DNA-methyltransferase promoter methylation status must be determined
Participants must not have had any prior therapy for glioblastoma multiforme including radiation or chemotherapy.
Participants must be > 70 years of age.
Participants must have life expectancy greater than 6 months.
Karnofsky performance status > 60 (ECOG < 2).
Patients must have normal organ and marrow function
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiao Woo, MD | James Graham Brown Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Temozolomide | Drug | 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. |
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| From date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, PI decision) or death from any cause, whichever is first, assessed up to 100 months. |
| Tolerability (feasibility) of hypo-fractionated radiaton therapy and Temozolomide | Quality of life will be measured by Fact-BR assessment. | From date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, PI decision) or death from any cause, whichever is first, assessed up to 100 months. |
| From date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, PI decision) or death from any cause, whichever is first, assessed up to 100 months. |
| Explore changes in quality of life (QOL) | To explore changes in QOL measured by Functional Assessment of Cancer Therapy (FACT-BR) and its predictors. | 14-28 days after surgery then within 4 weeks from end of chemotherapy-radiation then 1,4, and 6 months post initiation of adjuvant treatment |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D003606 |
| Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |