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Radiation Therapy

High-Dose Radiation + Temozolomide for Glioblastoma

Phase 2

Waitlist Available

Led By Minesh Mehta

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status >= 70 within 28 days prior to step 2 registration

Age >= 18

Must not have

- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration

- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well two types of radiation therapy work compared to standard radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include typical reactions associated with radiation therapy such as fatigue, skin irritation at the treatment site, hair loss, headache, nausea; and those related to temozolomide like low blood counts leading to increased infection risk, nausea/vomiting, constipation/diarrhea, loss of appetite.

Eligibility Criteria

Inclusion Criteria

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

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

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I am 18 years old or older.

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I had a brain MRI within 3 days after surgery showing a tumor or surgery area under 5 cm.

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My diagnosis of glioblastoma has been confirmed by a central review.

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My tumor tissue is enough for MGMT status analysis.

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I can provide at least 1 block of tumor tissue for the study, preferably 2.

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My GBM tumor is located only in the upper part of my brain.

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My diagnosis was confirmed through surgery, not just a biopsy or CUSA.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on IV antibiotics for a bacterial or fungal infection.

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I am not pregnant and willing to use contraception if of childbearing potential.

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I have not used Gliadel wafers or similar treatments.

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I have a serious heart rhythm problem that is not well controlled.

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My cancer has spread from its original location.

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I do not have a severe lung condition that requires hospital care right now.

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I have end-stage kidney disease and need dialysis.

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I've had radiation therapy to my head or neck, not for early-stage vocal cord cancer.

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My tumor and the area operated on are larger than 5 cm.

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My brain tumor has come back or is found in multiple places.

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I have unstable chest pain.

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I was hospitalized for heart failure within the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absorptiometry, Photon

Secondary study objectives

Change in CD4 lymphopenia count

Change in neurocognitive function, as measured by Hopkins' Verbal Learning Test-Revised, Trail Making Test Parts A and B, and Controlled Oral Word Association Test

Change in perceived cognitive function, as measured by M.D. Anderson Symptom Inventory Brain Tumor

+4 more

Side effects data

From 2022 Phase 3 trial • 289 Patients • NCT01672892

77%

Diarrhea

73%

Fatigue

39%

Nausea

37%

Abdominal pain

30%

Urinary frequency

21%

Anemia

21%

Constipation

21%

Anorexia

18%

Urinary incontinence

18%

Pelvic pain

17%

White blood cell decreased

16%

Edema limbs

16%

Pain

13%

Dyspnea

13%

Vomiting

13%

Headache

12%

Paresthesia

11%

Lymphocyte count decreased

10%

Bloating

10%

Cough

10%

Hypomagnesemia

10%

Urinary tract pain

10%

Urinary urgency

10%

Urinary tract infection

10%

Hot flashes

10%

Insomnia

Platelet count decreased

Rectal pain

Gastrointestinal disorders - Other

Proctitis

Hyperglycemia

Hyponatremia

Anxiety

Renal and urinary disorders - Other

Weight loss

Depression

Cystitis noninfective

Alopecia

Tinnitus

Blurred vision

Neutrophil count decreased

Hypokalemia

Back pain

Generalized muscle weakness

Peripheral sensory neuropathy

Vaginal discharge

Vaginal hemorrhage

Pruritus

Hypertension

Dermatitis radiation

Dyspepsia

Hypoalbuminemia

Rectal hemorrhage

Vaginal stricture

Arthralgia

Skin and subcutaneous tissue disorders - Other

Device related infection

Vaginal pain

100%

80%

60%

40%

20%

Study treatment Arm

Intensity-Modulated Radiation Therapy

Standard Radiation Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm C (proton beam radiation therapy)Experimental Treatment3 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 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (photon IMRT)Experimental Treatment4 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 courses in the absence of disease progression or unacceptable toxicity.

Group III: Arm A1 (control)Active Control4 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 courses in the absence of disease progression or unacceptable toxicity.

Group IV: Arm A2 (control)Active Control4 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 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

proton beam radiation therapy

2010

Completed Phase 2

~90

temozolomide

2008

Completed Phase 2

~1060