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Intraoperative Radiotherapy for Glioblastoma (INTRAGO-II Trial)

Phase 3

Waitlist Available

Led By Frank A. Giordano, MD

Research Sponsored by Universitätsmedizin Mannheim

Eligibility Criteria Checklist

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

Must have

Patients must have adequate organ functions: Bone marrow function - Platelets ≥ 75.000/μL, WBC ≥ 3.000/μL, Hemoglobin ≥ 10.0 g/dL; Liver Function - ASAT and ALAT ≤ 3.0 times ULN, ALP ≤ 2.5 times ULN, Total Serum Bilirubin < 1.5 times ULN; Renal Function - Serum Creatinine ≤ 1.5 times ULN

Age ≥18 and ≤ 80 years

Must not have

Exclusion Criteria Related to Surgery: Active egress of fluids from a ventricular defect, In-field risk organs and/or IORT dose >8 Gy to any risk organ

Previous cranial radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing if adding intraoperative radiotherapy (IORT) to standard radiochemotherapy can improve the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM).

Who is the study for?

This trial is for adults aged 18-80 with newly diagnosed glioblastoma who are fit enough for surgery (KPS ≥ 60%) and have the tumor in a specific brain region. They must have good organ function, no prior anti-cancer treatments like bevacizumab or cranial radiation, not be pregnant or breastfeeding, and agree to use contraception.

What is being tested?

The INTRAGO II trial is checking if adding intraoperative radiotherapy (IORT) to standard treatment improves survival without cancer growth in glioblastoma patients. It's a phase III study where participants are randomly assigned to receive either the new approach or just the standard care.

What are the potential side effects?

Potential side effects include those from standard surgery and radiochemotherapy such as fatigue, hair loss, skin irritation at the treatment site, nausea, headaches, seizures due to swelling or bleeding in the brain post-surgery. IORT may also carry risks of additional localized damage.

Eligibility Criteria

Inclusion Criteria

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

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My blood, liver, and kidney functions meet the required levels.

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I am between 18 and 80 years old.

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I can care for myself but may need occasional help.

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My brain tumor can be completely removed by surgery.

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My doctor says I can have targeted radiation during surgery.

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My diagnosis is glioblastoma based on tissue examination.

Exclusion Criteria

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

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I do not have fluid leaking from a brain ventricle defect or risk of high radiation dose to vital organs.

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I have had radiation therapy to my brain before.

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I do not have any health conditions that doctors say will shorten my life to under 5 years.

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My cancer is in multiple areas or has spread too much to be surgically removed.

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I have been treated with drugs that block blood vessel growth.

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I refuse to use birth control during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Median Progression-Free Survival

Secondary study objectives

Activities of daily living (ADL), assessed using the Barthel Index (Mahoney & Barthel, 1965).

OS with respect to Age

OS with respect to KPS

+11 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Arm (A)Experimental Treatment4 Interventions

Standard surgery plus intraoperative radiotherapy (20-30 Gy) followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).

Group II: Control Arm (B)Active Control3 Interventions

Standard surgery followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiochemotherapy

2016

Completed Phase 2

~810

Temozolomide

2010

Completed Phase 3

~1880