Intraoperative Radiotherapy for Glioblastoma
(INTRAGO-II Trial)

Recruiting in Palo Alto (17 mi)

+21 other locations

Overseen byFrank A. Giordano, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Universitätsmedizin Mannheim

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical phase III trial which tests if the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of intraoperative radiotherapy (IORT) to standard radiochemotherapy.

Eligibility Criteria

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.

Inclusion Criteria

I understand the nature and personal implications of participating in this clinical trial.

My brain tumor can be completely removed by surgery.

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

+6 more

Exclusion Criteria

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

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

I have not had chemotherapy for cancer in the last 5 years.

+7 more

Participant Groups

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.

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).