Proton Beam Radiation Therapy for Glioma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Glioma+9 More
Proton Beam Radiation Therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying proton beam radiation therapy and intensity-modulated radiation therapy to see how well they work in preserving brain function in patients with IDH mutant grade II or III glioma.

Eligible Conditions
  • Glioma
  • Anaplastic Astrocytoma (AA)
  • Oligoastrocytoma
  • 1p/19q Co-deletion
  • Oligodendroglioma
  • IDH1 Gene Mutation
  • IDH2 Gene Mutation
  • Diffuse Astrocytoma

Treatment Effectiveness

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Up to 10 years

Year 10
Cognition
Change in symptoms as measured by MDASI-BT
Year 10
Progression-free survival (PFS)
Year 10
Overall survival (OS)
Up to 10 years
Assessment of dose-response relationships
Assessment of tumor molecular status
Change in quality of life as measured by the LASA scale
Cognition as measured by COWA
Cognition as measured by HVLT-R
Cognition as measured by TMT parts A and B
Incidence of adverse events (AEs) graded according to the National Cancer Institute's Common Terminology for Adverse Events version 4.0
Local control as assessed by RANO criteria

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel)
71%Cough
69%Dysphagia
54%Dermatitis
40%Anorexia
23%Constipation
11%Dehydration
6%Fatigue
6%Nausea
6%Pneumonitis
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02073968) in the Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel) ARM group. Side effects include: Cough with 71%, Dysphagia with 69%, Dermatitis with 54%, Anorexia with 40%, Constipation with 23%.

Trial Design

2 Treatment Groups

Arm I (photon-based IMRT, temozolomide)
1 of 2
Arm II (proton beam radiation therapy, temozolomide)
1 of 2

Active Control

Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: Proton Beam Radiation Therapy · No Placebo Group · Phase 2

Arm II (proton beam radiation therapy, temozolomide)Experimental Group · 2 Interventions: Proton Beam Radiation Therapy, Temozolomide · Intervention Types: Radiation, Drug
Arm I (photon-based IMRT, temozolomide)ActiveComparator Group · 2 Interventions: Temozolomide, IMRT (Intensity-Modulated Radiation Therapy) · Intervention Types: Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton Beam Radiation Therapy
2013
Completed Phase 2
~50
Temozolomide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years

Who is running the clinical trial?

NRG OncologyLead Sponsor
216 Previous Clinical Trials
93,648 Total Patients Enrolled
2 Trials studying Glioma
218 Patients Enrolled for Glioma
National Cancer Institute (NCI)NIH
13,000 Previous Clinical Trials
41,300,787 Total Patients Enrolled
279 Trials studying Glioma
59,200 Patients Enrolled for Glioma
David GrosshansPrincipal InvestigatorNRG Oncology

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
is associated with a significantly increased risk of mortality Having an absolute neutrophil count (ANC) of >= 1,500 cells/mm^3 is associated with a significantly increased risk of mortality.
A hemoglobin level of 10 or higher is considered acceptable.
The person provides documentation from the enrolling site that confirms the presence of the IDH mutation and 1p/19q status
You must provide informed consent prior to study entry.
Tumor tissue must be available for submission for central pathology review.
The patient had a Karnofsky performance status of >= 70 within 30 days prior to registration.
A platelet count of at least 100,000 cells per cubic millimeter is considered high.
This means that the level of bilirubin in a person's blood is lower than 1.5 times the upper limit of what is considered normal.
You are eligible if you are English speaking.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: November 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.