← Back to Search

Temozolomide + Radiation Therapy for Brain Cancer (CATNON Trial)

Phase 3
Waitlist Available
Research Sponsored by European Organisation for Research and Treatment of Cancer - EORTC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Absence of combined 1p/19q loss
Histologically confirmed diagnosis of anaplastic oligodendroglioma, anaplastic oligoastrocytoma, anaplastic astrocytoma, or newly diagnosed disease
Must not have
No prior radiotherapy to the brain
No prior chemotherapy, including carmustine-containing wafers (Gliadel®)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 14 days prior to randomization till five years or death (time till death is up to 10.9 years after patient enrollment in the study)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is studying giving temozolomide during and/or after radiation therapy to see if it is more effective than radiation therapy alone in treating patients with anaplastic glioma.

Who is the study for?
This trial is for adults with a specific type of brain tumor called anaplastic glioma without 1p/19q LOH. They should have normal liver function, not be pregnant or nursing, and able to use contraception. Patients must have stable health without serious conditions affecting medication intake or follow-up, no HIV/hepatitis infections, and acceptable blood counts.
What is being tested?
The study compares the effectiveness of radiation therapy alone versus in combination with temozolomide chemotherapy in treating anaplastic glioma. Participants are randomly assigned to receive either just radiation or both treatments to see which works better at killing tumor cells.
What are the potential side effects?
Radiation may cause fatigue, skin changes, headaches, nausea; while temozolomide can lead to low blood cell counts increasing infection risk, nausea/vomiting, constipation/diarrhea, loss of appetite and hair thinning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer does not have a specific genetic feature (1p/19q loss).
Select...
My diagnosis is a specific type of aggressive brain tumor.
Select...
I can take care of myself and perform daily activities.
Select...
I can take pills without any issues.
Select...
I have no history of cancer at sites other than the current one.
Select...
I do not have HIV, hepatitis B, or hepatitis C.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had radiation treatment to my brain.
Select...
I have not had chemotherapy or used Gliadel wafers.
Select...
I am not using growth factors unless absolutely necessary.
Select...
I am not taking any other cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 14 days prior to randomization till five years or death (time till death is up to 10.9 years after patient enrollment in the study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 14 days prior to randomization till five years or death (time till death is up to 10.9 years after patient enrollment in the study) 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 as Measured From the Day of Randomization
Secondary study objectives
Neurological Deterioration Free Survival
Progression-free Survival
Quality of Life of the Patient

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Active Control
Group I: Radiotherapy (RT) aloneActive Control4 Interventions
radiation therapy alone
Group II: RT & Concurrent CTActive Control5 Interventions
Radiotherapy and concurrent temozolomide chemotherapy
Group III: RT + Adjuvant CTActive Control6 Interventions
Radiotherapy plus adjuvant temozolomide chemotherapy
Group IV: RT & Concurrent CT + adjuvant CTActive Control6 Interventions
Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy

Find a Location

Who is running the clinical trial?

European Organisation for Research and Treatment of Cancer - EORTCLead Sponsor
414 Previous Clinical Trials
164,859 Total Patients Enrolled
NCIC Clinical Trials GroupNETWORK
189 Previous Clinical Trials
144,090 Total Patients Enrolled
Cooperative Trials Group for Neuro-OncologyUNKNOWN
1 Previous Clinical Trials
103 Total Patients Enrolled
Medical Research CouncilOTHER_GOV
321 Previous Clinical Trials
1,992,283 Total Patients Enrolled
Radiation Therapy Oncology GroupNETWORK
190 Previous Clinical Trials
64,173 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,027 Previous Clinical Trials
5,188,052 Total Patients Enrolled
Anna Nowak, MDStudy ChairSir Charles Gairdner Hospital - Nedlands
1 Previous Clinical Trials
214 Total Patients Enrolled
S. ErridgeStudy ChairMedical Research Council
Wolfgang WickStudy ChairUniversitatsklinikum Heidelberg
2 Previous Clinical Trials
523 Total Patients Enrolled
Warren P. Mason, MDStudy ChairPrincess Margaret Hospital, Canada
1 Previous Clinical Trials
32 Total Patients Enrolled

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT00626990 — Phase 3
Brain Tumor Research Study Groups: Radiotherapy (RT) alone, RT & Concurrent CT, RT + Adjuvant CT, RT & Concurrent CT + adjuvant CT
Brain Tumor Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT00626990 — Phase 3
Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT00626990 — Phase 3
~42 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top