Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria. 1. Age ≥18 and ≤ 80 years. 2. Karnofsky Performance Score (KPS) ≥ 60% 3. Supratentorial T1-Gd enhancing lesion(s) amenable to total resection. 4. Legal capacity and ability of subject to understand character and individual consequences of the clinical trial. 5. Patient's written IC obtained at least 24h prior to surgery. 6. For women with childbearing potential: adequate contraception. 7. 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.

Inclusion Criteria Related to Surgery: 8. IORT must be technically feasible. 9. Histology supports diagnosis of GBM. Exclusion Criteria. 1. Multicentric disease (e.g. in both hemispheres) or non-resectable satellite lesions. 2. Previous cranial radiation therapy. 3. Cytostatic therapy / chemotherapy for cancer within the past 5 years. 4. History of cancers or other comorbidities that limit life expectancy to less than five years. 5. Previous therapy with anti-angiogenic substances (such as bevacizumab) 6. Technical impossibility to use MRI or known allergies against MRI and/or CT contrast agents. 7. Participation in other clinical trials testing cancer-derived investigational agents/procedures. 8. Pregnant or breast feeding patients. 9. Fertile patients refusing to use safe contraceptive methods during the study. Exclusion Criteria Related to Surgery: 10. Active egress of fluids from a ventricular defect. 11. In-field risk organs and/or IORT dose >8 Gy to any risk organ

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02685605
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Universitätsmedizin Mannheim
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Frank A. Giordano, MDKevin Petrecca, MD
Principal Investigator Affiliation	Department of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, GermanyDepartment of Neurosurgery, Montréal Neurological, Institute and Hospital, Montréal, Canada
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	Brazil, Canada, China, Germany, Korea, Republic of, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Arms & Interventions

Arms

Experimental: Experimental Arm (A)

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).

Active Comparator: Control Arm (B)

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).

Interventions

Procedure: - Standard surgery

Radiation: - Intraoperative radiotherapy

Dose to applicator surface: 20-30 Gy; Carl Zeiss INTRABEAM System. IORT with a surface dose of 30 Gy is recommended.Should the proximity to any risk structure not allow to apply 30 Gy, a dose reduction by up to 10 Gy (resulting in a surface dose of 20 Gy) is allowed.

Radiation: - Radiochemotherapy

EBRT to 60 Gy plus 75 mg/m2/d temozolomide

Drug: - Temozolomide

Adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Barrow Neurological Institute (SJHMC), Phoenix, Arizona

Status

Not yet recruiting

Address

Barrow Neurological Institute (SJHMC)

Phoenix, Arizona, 85013

Site Contact

Lisa Arnold

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