Temozolomide + Radiation Therapy for Brain Cancer

(CATNON Trial)

Recruiting in Palo Alto (17 mi)

+136 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma. PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.

Research Team

Anna Nowak, MD

Principal Investigator

Sir Charles Gairdner Hospital - Nedlands

S. Erridge

Principal Investigator

Medical Research Council

Wolfgang Wick

Principal Investigator

Universitatsklinikum Heidelberg

Warren P. Mason, MD

Principal Investigator

Princess Margaret Hospital, Canada

Michael A. Vogelbaum, MD, PhD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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.

Inclusion Criteria

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

Fertile patients must use effective contraception

No psychological, familial, sociological, or geographical condition that would potentially hamper compliance

Exclusion Criteria

I have not had radiation treatment to my brain.

I have not had chemotherapy or used Gliadel wafers.

I am not using growth factors unless absolutely necessary.

Treatment Details

Interventions

• Adjuvant Therapy (Procedure)
• Radiation Therapy (Radiation)
• Temozolomide (Alkylating agents)

Trial Overview 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.

Participant Groups

Group I: Radiotherapy (RT) alone Active Control 4 Interventions

radiation therapy alone

Group II: RT & Concurrent CT Active Control 5 Interventions

Radiotherapy and concurrent temozolomide chemotherapy

Group III: RT + Adjuvant CT Active Control 6 Interventions

Radiotherapy plus adjuvant temozolomide chemotherapy

Group IV: RT & Concurrent CT + adjuvant CT Active Control 6 Interventions

Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy

Radiation Therapy is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

European Organisation for Research and Treatment of Cancer - EORTC

Lead Sponsor

Trials

417

Recruited

166,000+

Dr. Vassilis Golfinopoulos

European Organisation for Research and Treatment of Cancer - EORTC

Chief Medical Officer

MD

Dr. Denis Lacombe

European Organisation for Research and Treatment of Cancer - EORTC

Chief Executive Officer

MD, MSc

NCIC Clinical Trials Group

Collaborator

Trials

190

Recruited

145,000+

Dr. Lesley Seymour

NCIC Clinical Trials Group

Chief Medical Officer since 2014

MD from University of Toronto

Dr. Janet Dancey

NCIC Clinical Trials Group

Chief Executive Officer since 2014

MD from Queen's University

Cooperative Trials Group for Neuro-Oncology

Collaborator

Trials

2

Recruited

850+

Medical Research Council

Collaborator

Trials

327

Recruited

1,999,000+

Dr. Ceri Williams

Medical Research Council

Chief Medical Officer

MD

Professor Patrick Chinnery

Medical Research Council

Executive Chair

MBBS, PhD in Clinical Neuroscience

Radiation Therapy Oncology Group

Collaborator

Trials

191

Recruited

64,900+

Dr. Vivek S. Kavadi

Radiation Therapy Oncology Group

Chief Executive Officer

MD from Harvard Medical School, MBA from The Wharton School

Dr. Gita Suneja

Radiation Therapy Oncology Group

Chief Medical Officer

MD from University of Utah School of Medicine

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University