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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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.
James Graham Brown Cancer Center
Louisville, Kentucky, United States
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.
Time frame: 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.
Time frame: 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.
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.
Time frame: 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.
Time frame: 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.
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