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Radiation Therapy

Hypofractionated radiation therapy for Glioblastoma

Phase 2
Waitlist Available
Led By Samir Patel, MD
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated at baseline, weekly during radiation therapy, at the end of every 2 cycles of adjuvant temozolomide, and post-treatment follow-up every 4 months for 2 years, then every 6 months for years 3-5 up until progression/palliative
Awards & highlights

Summary

This study is being done to compare standard radiation therapy with hypofractionated radiation therapy for patients with newly diagnosed glioblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated weekly during radiation therapy; on c1d1 and at the end of every 2 cycles of adjuvant temozolomide; post-treatment follow-up every 4 months for 2 years, then every 6 months for years 3-5 up until progression/palliative
This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated weekly during radiation therapy; on c1d1 and at the end of every 2 cycles of adjuvant temozolomide; post-treatment follow-up every 4 months for 2 years, then every 6 months for years 3-5 up until progression/palliative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall survival
Secondary study objectives
Adverse events according to NCI CTCAE version 4.0 criteria.
Health-related quality-of-life as assessed by MMSE and EORTC QLQ-C30/QLQ-BN20 questionnaires.
Progression-free survival (PFS)

Side effects data

From 2014 Phase 1 trial • 9 Patients • NCT00841555
100%
Fatigue
67%
Vision changes
33%
Dry skin
33%
Headache
33%
Alopecia
33%
Nausea
33%
Constipation
33%
Hypertension
33%
Anorexia
33%
High ALT
33%
Insomnia
33%
Diarrhea
33%
Low Calcium
100%
80%
60%
40%
20%
0%
Study treatment Arm
50 mg/m2
65 mg/m2
75 mg/m2

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Hypofractionated radiation therapyExperimental Treatment1 Intervention
Hypofractionated radiation therapy of 60 Gy in 20 fractions (3 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 4-week break, temozolomide days 1-5 every 28 days for 6-12 cycles(as per institutional standard)..
Group II: Standard radiation therapyActive Control1 Intervention
Standard radiation therapy of 60 Gy in 30 fractions (2 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 4-week break, temozolomide days 1-5 every 28 days for 6-12 cycles(as per institutional standard)..
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated radiation therapy
2009
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
26,698 Total Patients Enrolled
7 Trials studying Glioblastoma
276 Patients Enrolled for Glioblastoma
Cross Cancer InstituteOTHER
61 Previous Clinical Trials
19,057 Total Patients Enrolled
1 Trials studying Glioblastoma
26 Patients Enrolled for Glioblastoma
Samir Patel, MDPrincipal InvestigatorCross Cancer Institute
2 Previous Clinical Trials
111 Total Patients Enrolled
1 Trials studying Glioblastoma
~12 spots leftby Sep 2025
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