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Temozolomide + Radiation Therapy for Brain Cancer (CATNON Trial)

Q: Are there any other instances of research teams using radiation therapy in combination with chemotherapy?

Currently, 219 clinical trials for RT &#x26; Concurrent CT are ongoing worldwide with 25 of those trials in Phase 3. RT &#x26; Concurrent CT trials are being conducted in 4738 locations, with several of those trials taking place in Seoul, Songpa.

Q: Has the FDA cleared RT & Concurrent CT for use?

RT &#x26; Concurrent CT is considered safe based on our estimation because it is a phase 3 trial, meaning that not only is there some evidence of its efficacy, but multiple rounds of data support its safety.

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

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

CATNON 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.Check my eligibility

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.See study design

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.

CATNON Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer does not have a specific genetic feature (1p/19q loss).

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My diagnosis is a specific type of aggressive brain tumor.

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I can take care of myself and perform daily activities.

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I can take pills without any issues.

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I have no history of cancer at sites other than the current one.

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I do not have HIV, hepatitis B, or hepatitis C.

CATNON Trial Timeline

Screening ~ 3 weeks3 visits

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)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival as Measured From the Day of Randomization

Secondary outcome measures

Neurological Deterioration Free Survival

Progression-free Survival

Quality of Life of the Patient

CATNON 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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

European Organisation for Research and Treatment of Cancer - EORTCLead Sponsor

412 Previous Clinical Trials

164,333 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

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

Frequently Asked Questions

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

Is this study being conducted in many different locations within the city?

"Patients are currently being recruited from 77 different locations, including Dixie Medical Center Regional Cancer Center in Saint George, Utah, Cancer Centers of the Carolinas - Eastside in Greenville, South carolina, and University of Rochester - James P. Wilmot Cancer Center in Rochester, New york."

Answered by AI

Are there any other instances of research teams using radiation therapy in combination with chemotherapy?

"Currently, 219 clinical trials for RT & Concurrent CT are ongoing worldwide with 25 of those trials in Phase 3. RT & Concurrent CT trials are being conducted in 4738 locations, with several of those trials taking place in Seoul, Songpa."

Answered by AI

Could you please tell me how many individuals are being observed in this clinical trial?

"At the moment, this study does not require any more participants. It was initially posted on December 1st, 2007 and was last updated on May 9th, 2022. Other options include 116 trials for brain and central nervous system tumors and 219 studies for RT & Concurrent CT."

Answered by AI

Has the FDA cleared RT & Concurrent CT for use?

"RT & Concurrent CT is considered safe based on our estimation because it is a phase 3 trial, meaning that not only is there some evidence of its efficacy, but multiple rounds of data support its safety."

Answered by AI

If I join this program, will I be able to see the benefits?

"This trial is looking for 751 participants that have brain or central nervous system tumors. The ages of those patients should be between 18 and 120 years old."

Answered by AI

Does this research exclude geriatric patients?

"This particular clinical trial is only for patients aged 18 to 120. However, there are a total of 122 clinical trials for people who fall under the age of 18 and 234 trials for those over the age of 65."

Answered by AI

What maladies have been shown to respond best to radiation therapy in combination with chemotherapy?

"Concurrent radiation therapy and chemotherapy is a common treatment for patients with nitrosourea. However, this type of treatment can also be effective for other conditions, such as refractory neuroblastoma and advanced mycosis fungoides."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Adjuvant and Concurrent Temozolomide for 1p/19q Non-co-deleted Anaplastic Glioma (CATNON; EORTC Study 26053-22054): Second Interim Analysis of a Randomised, Open-label, Phase 3 Study

van den Bent, Martin J, C Mircea S Tesileanu, Wolfgang Wick, Marc Sanson, Alba Ariela Brandes, Paul M Clement, Sarah Erridge, et al.. 2021. “Adjuvant and Concurrent Temozolomide for 1p/19q Non-co-deleted Anaplastic Glioma (CATNON; EORTC Study 26053-22054): Second Interim Analysis of a Randomised, Open-label, Phase 3 Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(21)00090-5.

The LancetJournal

Interim Results from the CATNON Trial (EORTC Study 26053-22054) of Treatment with Concurrent and Adjuvant Temozolomide for 1p/19q Non-co-deleted Anaplastic Glioma: A Phase 3, Randomised, Open-label Intergroup Study

van den Bent, Martin J, Brigitta Baumert, Sara C Erridge, Michael A Vogelbaum, Anna K Nowak, Marc Sanson, Alba Ariela Brandes, et al.. 2017. “Interim Results from the CATNON Trial (EORTC Study 26053-22054) of Treatment with Concurrent and Adjuvant Temozolomide for 1p/19q Non-co-deleted Anaplastic Glioma: A Phase 3, Randomised, Open-label Intergroup Study”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(17)31442-3.

idhJournal

Temozolomide and Radiotherapy Versus Radiotherapy Alone in Patients with Glioblastoma, idh-wildtype: post Hoc Analysis of the EORTC Randomized Phase III CATNON Trial

Tesileanu, C. Mircea S., Marc Sanson, Wolfgang Wick, Alba A. Brandes, Paul M. Clement, Sara C. Erridge, Michael A. Vogelbaum, et al.. 2022. “Temozolomide and Radiotherapy Versus Radiotherapy Alone in Patients with Glioblastoma, idh-wildtype: post Hoc Analysis of the EORTC Randomized Phase III CATNON Trial”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-4283.

clinicaltrials.govStudy