Radiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma

Recruiting in Palo Alto (17 mi)

+94 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Radiation Therapy Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients who have anaplastic oligodendroglioma.

Research Team

Richard M. Hellman, MD

Principal Investigator

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

J. Gregory Cairncross, MD

Principal Investigator

London Health Sciences Centre

Karen L. Fink, MD, PhD

Principal Investigator

Simmons Cancer Center

Normand Laperriere, MD, FRCPC

Principal Investigator

Princess Margaret Hospital, Canada

Steven R. Alberts, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

Histologically proven unifocal or multifocal, supratentorial, pure or mixed anaplastic oligodendroglioma

Prior suspected or proven low-grade glioma allowed if current histologic proof of pure or mixed anaplastic oligodendroglioma

Tumor must contain an unequivocal (at least 25%) oligodendroglial element and have 2 or more anaplastic features, 1 of which must be frequent mitoses or endothelial proliferation

Treatment Details

Interventions

• Lomustine (Alkylating agents)
• Procarbazine Hydrochloride (Alkylating agents)
• Radiation Therapy (Radiation)
• Vincristine Sulfate (Vinca alkaloids)

Participant Groups

Group I: Intensive pre-treatment chemotherapy and radiation therapy Experimental Treatment 4 Interventions

Intensive pre-treatment chemotherapy (Day 1 CCNU 130 mg/m2 p.o., Day 8 - Vincristine 1.4 mg/m2 i.v., Days 8-21 - Procarbazine 75 mg/m2 p.o., Day 29 - Vincristine 1.4 mg/m2 i.v.) followed by radiation therapy (External Beam RT 59.4 Gy (1.8 Gy x 33 fractions, 5 days a week) to MR defined tumor volume).

Group II: Radiation therapy (RT) alone Active Control 1 Intervention

Radiation therapy (RT) alone - External Beam RT 59.4 Gy (1.8 Gy x 33 fractions, 5 days a week) to MR defined tumor volume.

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?

Radiation Therapy Oncology Group

Lead Sponsor

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

Southwest Oncology Group

Collaborator

Trials

389

Recruited

260,000+

Dr. Lyudmila Bazhenova

Southwest Oncology Group

Chief Medical Officer since 2021

MD from University of California, San Diego

Dr. Richard Schilsky

Southwest Oncology Group

Chief Executive Officer since 2013

MD from University of California, San Diego

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

North Central Cancer Treatment Group

Collaborator

Trials

49

Recruited

81,100+

SWOG Cancer Research Network

Collaborator

Trials

403

Recruited

267,000+

Dr. Charles D. Blanke

SWOG Cancer Research Network

Chief Executive Officer since 2012

MD from Oregon Health & Science University

Dr. Dawn Hershman

SWOG Cancer Research Network

Chief Medical Officer since 2020

MD from Columbia University

Eastern Cooperative Oncology Group

Collaborator

Trials

272

Recruited

153,000+

Dr. Mitchell D. Schnall

Eastern Cooperative Oncology Group

Chief Medical Officer

MD, PhD from University of Pennsylvania

Dr. Peter J. O'Dwyer

Eastern Cooperative Oncology Group

Chief Executive Officer

MD from University of Pennsylvania

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