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Intraoperative Radiotherapy for Glioblastoma (INTRAGO-II Trial)

Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

INTRAGO-II 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.Check my eligibility
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.See study design
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.

INTRAGO-II Trial 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.

INTRAGO-II Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median Progression-Free Survival
Secondary outcome measures
Activities of daily living (ADL), assessed using the Barthel Index (Mahoney & Barthel, 1965).
Median Overall Survival
OS with respect to Age
+12 more

INTRAGO-II 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
~1930

Find a Location

Who is running the clinical trial?

Universitätsmedizin MannheimLead Sponsor
100 Previous Clinical Trials
31,457 Total Patients Enrolled
2 Trials studying Glioblastoma
62 Patients Enrolled for Glioblastoma
Carl Zeiss Meditec AGIndustry Sponsor
41 Previous Clinical Trials
7,640 Total Patients Enrolled
University of California, Los AngelesOTHER
1,521 Previous Clinical Trials
10,278,622 Total Patients Enrolled
4 Trials studying Glioblastoma
156 Patients Enrolled for Glioblastoma

Media Library

Radiochemotherapy Clinical Trial Eligibility Overview. Trial Name: NCT02685605 — Phase 3
Glioblastoma Research Study Groups: Experimental Arm (A), Control Arm (B)
Glioblastoma Clinical Trial 2023: Radiochemotherapy Highlights & Side Effects. Trial Name: NCT02685605 — Phase 3
Radiochemotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02685605 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any dangers associated with Radiochemotherapy?

"Radiochemotherapy received a score of 3 because there is both efficacy and safety data from Phase 3 clinical trials."

Answered by AI

How many test subjects are involved in this experiment?

"In order to run this experiment, the sponsors need a total of 314 patients that meet certain conditions. The trial will be conducted by Carl Zeiss Meditec AG at various locations, two examples being West virginia University and Barrow Neurological Institute."

Answered by AI

What is the usual purpose of Radiochemotherapy?

"Radiochemotherapy is not only an effective treatment for nitrosourea, but also other diseases such as advance directives, refractory, advanced mycosis fungoides and refractory neuroblastoma."

Answered by AI

Is this study currently looking for new participants?

"The listing on clinicaltrials.gov says that this study is open for recruitment and is currently looking for 314 patients at 6 locations. The trial was created on December 9th, 2016 with the most recent update being from May 17th, 2022."

Answered by AI

Is this a groundbreaking clinical trial?

"Radiochemotherapy has been under clinical investigation since 2002. The first trial was sponsored by Schering-Plough and took place in the same year. Sixty patients were enrolled in the study, which ultimately led to Phase 2 drug approval for Radiochemotherapy. As of now, there are 219 active trials involving Radiochemotherapy being conducted in 947 cities across 38 countries."

Answered by AI

Is there precedent for this combination of treatments?

"There are a total of 219 clinical trials studying radiochemotherapy, with 25 of those being in the third and final stage. The majority of these trials originate from Seoul and Songpa in South Korea, but there are 4829 locations worldwide where research is being conducted."

Answered by AI

Does this research project have an age limit for participants?

"The age range for eligible patients in this trial is 18 to 80 years old."

Answered by AI

Could you please estimate the number of hospitals that are running this trial?

"There are 6 enrolling patients for this trial such as West virginia University in Morgantown, Barrow Neurological Institute (SJHMC) in Phoenix, and Long Island Jewish Medical Center, North Shore University Hospital in Lake Success. In addition to these locations, there are 6 other centres where you can participate."

Answered by AI
Recent research and studies
~38 spots leftby Mar 2025