High-Dose Radiation + Temozolomide for Glioblastoma

Recruiting at258 trial locations

Overseen by Minesh P Mehta

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: NRG Oncology

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT or proton beam radiation therapy is more effective than standard-dose radiation therapy with temozolomide in treating glioblastoma.

Research Team

Minesh P Mehta

Principal Investigator

NRG Oncology

Eligibility Criteria

Adults with newly diagnosed glioblastoma located in the supratentorial compartment, who have undergone surgery and are able to undergo MRI scans. Participants must not have had prior invasive malignancies (except certain skin cancers) within 3 years or any previous chemotherapy for head and neck cancer (excluding temozolomide). They should be free from serious medical conditions that could interfere with the trial, not pregnant, willing to use contraception, and without a history of HIV/AIDS.

Inclusion Criteria

I can care for myself but cannot do normal activities without help.

History/physical examination within 28 days prior to step 2 registration

I am 18 years old or older.

Exclusion Criteria

I have not used Gliadel wafers or similar treatments.

I haven't had serious wounds, ulcers, fractures, or major surgeries in the last 28 days.

You have a very weak immune system due to a serious health condition.

Treatment Details

Interventions

• Photon Beam Radiation Therapy (Radiation Therapy)
• Proton Beam Radiation Therapy (Radiation Therapy)
• Temozolomide (Alkylating agents)

Trial Overview The study is testing if higher doses of photon IMRT or proton beam radiation therapy can be more effective than standard-dose radiation when combined with temozolomide in treating glioblastoma. The goal is to see if these intensified treatments better target tumors while sparing healthy tissue and enhancing sensitivity to medication.

Participant Groups

Group I: Arm C (proton beam radiation therapy) Experimental Treatment 5 Interventions

Patients undergo dose-escalated and -intensified proton beam therapy QD, 5 days a week for a total of 30 fractions. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (photon IMRT) Experimental Treatment 6 Interventions

Patients undergo dose-escalated and -intensified photon IMRT QD, 5 days a week for a total of 30 fractions. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Group III: Arm A1 (control) Active Control 6 Interventions

Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT QD, 5 days a week for 23 fractions plus a boost of 7 additional fractions. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Group IV: Arm A2 (control) Active Control 6 Interventions

Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT as in Arm A1. In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Photon Beam Radiation Therapy is already approved in Canada for the following indications:

Approved in Canada as Radiation Therapy for:

• Cancer treatment, including glioblastoma

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School

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

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