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A Study Using Radiation Therapy and Temozolomide to Treat Glioblastoma in Patients Over 70

NCT01985087 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-10-31

No results posted yet for this study

Summary

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.

Conditions

Interventions

RADIATION

Hypofractionated radiotherapy

Treatment of 3.4 Gy will be given daily 5 days per week over 2 weeks.

DRUG

Temozolomide

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.

Sponsors & Collaborators

  • James Graham Brown Cancer Center

    collaborator OTHER

  • University of Louisville

    lead OTHER

Principal Investigators

  • Shiao Woo, MD · James Graham Brown Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2025-05-31
Completion
2025-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01985087 on ClinicalTrials.gov