Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme

Phase 3Active Not RecruitingNCT02685605

Universitätsmedizin Mannheim314 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

314

Conditions

Glioblastoma

Interventions

Standard surgeryPROCEDURE

Intraoperative radiotherapyRADIATION

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.

RadiochemotherapyRADIATION

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (19)

Barrow Neurological Institute (SJHMC)

Phoenix, Arizona, United States

Stritch School of Medicine Loyola University

Maywood, Illinois, United States

Outcomes

Primary Outcomes

Median Progression-Free Survival

Determined according to modified Response Assessment in Neuro-Oncology (RANO) criteria and serial perfusion imaging

Time frame: 24 Months

Secondary Outcomes

Median Overall Survival

Time frame: 24 Months

PFS within a 1-2 cm margin around the cavity

Determined by serial contrast-enhanced MRI scans using modified RANO criteria and serial perfusion imaging

Time frame: 24 Months

OS with respect to Age

Median overall survival of patients \<65 vs. ≥ 65 years

Time frame: 24 Months

PFS with respect to Age

Progression-free survival of patients \<65 vs. ≥ 65 years; determined according to modified RANO criteria and serial perfusion imaging

Time frame: 24 Months

OS with respect to KPS

Median overall survival of patients with KPS 80-100% vs. 60-70%

Time frame: 24 Months

PFS with respect to KPS

Progression-free survival of patients with KPS 80-100% vs. 60-70%; determined according to modified RANO criteria and serial perfusion imaging

Time frame: 24 Months

OS with respect to thickness of anticipated T1-Gd-enhancing (remaining) tumor margin

Thickness of anticipated T1-Gd-enhancing (remaining) tumor margin as per the discretion of the surgeon (margin ≥0.5 cm or multiple spots of residual tumor within the cavity vs. \<0.5 cm)

Data from ClinicalTrials.gov

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