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Chemoradiotherapy vs Biomarker-Guided Therapy for Glioblastoma

Phase 2
Recruiting
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
Stable or decreasing dose of corticosteroids for at least 14 days prior to randomization.
Newly-diagnosed, histologically proven, intracranial glioblastoma with maximal safe resection. Biopsy alone is expected if resection is not possible. MGMT promoter methylation status must be tested for all patients.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study completion, up to 5 years.
Awards & highlights

Study Summary

This trial will compare overall survival of standard vs biomarker-guided therapy in elderly and frail patients with newly diagnosed GBM.

Who is the study for?
This trial is for elderly (age ≥ 65) GBM patients with a performance status KPS of 60-70. They must have newly-diagnosed, histologically proven glioblastoma and known MGMT promoter methylation status. Participants need stable organ function and agree to use effective birth control. Exclusions include prior invasive malignancies within 3 years, recent heart issues, active hepatitis B, or severe co-morbidities.Check my eligibility
What is being tested?
The study compares standard chemoradiotherapy (40 Gy radiation with concurrent temozolomide) against biomarker-guided therapy—either temozolomide alone for those with methylated MGMT promoters or just radiotherapy for non-methylated cases—to see which is better for survival without increasing toxicity.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, blood disorders like low platelet/white cell counts from temozolomide; skin irritation from radiation; and potential allergic reactions to medication components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My steroid dose has been stable or decreasing for the last 2 weeks.
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I have a new diagnosis of glioblastoma and have had surgery to remove as much as safely possible. My tumor's MGMT status is known.
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I agree not to donate sperm during and for six months after the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study completion, up to 5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study completion, up to 5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival
Secondary outcome measures
Cognitive and mental function
Cost effectiveness
Frequency of Adverse Events related to the treatment administered
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Biomarker based treatmentExperimental Treatment1 Intervention
MGMT (+) Temozolomide monotherapy: Patients will receive Temozolomide (TMZ) at a dose of 75 mg/m2 daily for 21 consecutive days. This will be followed by six cycles of TMZ according to the standard 5-day schedule (days 1-5) every 28 days. The dose will be 150 mg/m2 for the first cycle and increased to 200 mg/m2 beginning with the second cycle, so long as there are no hematologic adverse events. Dose will be determined using body surface area (BSA) calculation. MGMT methylation (-) RT monotherapy: Participants will receive radiation treatment with 40Gy / 15 fractions over a period of 21 days (3 weeks).
Group II: Standard Arm: TMZ with concurrent RT (combined modality arm)Active Control1 Intervention
Patients will receive a total of 21 days of Temozolomide (TMZ), with 15 days of TMZ administered daily with concurrent RT. TMZ will be delivered at a dose of 75 mg/m2, given daily with RT for 15 days, one hour before each session of RT. After a 4-week break, patients will receive six cycles of adjuvant TMZ according to the standard 5-day schedule (days 1-5) every 28 days, up to 6 cycles as tolerated by the patient. The dose will be 150 mg/m2 for the first cycle and increased to 200 mg/m2 beginning with the second cycle, so long as there are no hematologic adverse events, intractable nausea or fatigue.

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,091 Total Patients Enrolled
7 Trials studying Glioblastoma
288 Patients Enrolled for Glioblastoma

Media Library

Radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT04765514 — Phase 2
Glioblastoma Research Study Groups: Standard Arm: TMZ with concurrent RT (combined modality arm), Biomarker based treatment
Glioblastoma Clinical Trial 2023: Radiotherapy Highlights & Side Effects. Trial Name: NCT04765514 — Phase 2
Radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04765514 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent could patients be harmed by Biomarker-guided Temozolomide or Radiotherapy?

"Our team at Power gave a score of 2 to the safety rating for Biomarker-driven treatments, such as Temozolomide monotherapy or Radiotherapy monotherapy. This is due to existing data that supports its security, although no trials have been conducted yet on their effectiveness."

Answered by AI

Are there any remaining enrollments for this clinical experiment?

"Affirmative. Clinicaltrials.gov data suggests that this research is actively recruiting patients, with the trial being first posted on July 27th 2022 and recently updated on October 31st 2022. The study requires 121 participants to be recruited from 2 centres."

Answered by AI

What is the current capacity of participants for this investigation?

"Verified, the clinical trial is open for recruitment. As indicated on clinicaltrials.gov, this study was originally published on July 27th 2022 and recently updated on October 31st 2022. The research hopes to recruit 121 individuals from two medical sites."

Answered by AI

What medical issues can be addressed through Biomarker based treatment with Temozolomide or Radiotherapy?

"For those with refractory, advanced mycosis fungoides, nitrosourea treatment and advance directives can be augmented by Biomarker based therapies such as Temozolomide monotherapy or Radiotherapy."

Answered by AI

Does this research break new ground in its field?

"Currently, 207 trials are underway for Biomarker based treatment (Temozolomide monotherapy or Radiotherapy monotherapy) in 935 cities and 36 countries. This research first began with a Phase 2 study sponsored by Schering-Plough in 2002 which enrolled 60 participants; since then, 295 studies have been conducted."

Answered by AI

Has prior research demonstrated the efficacy of biomarker-centric therapies such as temozolomide monotherapies or radiotherapy monotherapies?

"At present, 207 clinical trials are actively investigating the use of Biomarker based treatment (Temozolomide monotherapy or Radiotherapy monotherapy), with 24 within Phase 3. Seoul and Songpa offer several studies related to this topic, while 4752 other locations are hosting such medical research."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Chemoradiotherapy Versus Biomarker-Guided Therapy for Elderly and Frail GBM Patients
2022. "Chemoradiotherapy Versus Biomarker-Guided Therapy for Elderly and Frail GBM Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04765514.
~81 spots leftby Jun 2032
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