Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme (INTRAGO-II)

U

Universitätsmedizin Mannheim

Status and phase

Enrolling
Phase 3

Conditions

Glioblastoma

Treatments

Procedure: Standard surgery
Drug: Temozolomide
Radiation: Intraoperative radiotherapy
Radiation: Radiochemotherapy

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02685605
ARO-2016-1 (Other Identifier)
INTRAGO-II
AG-NRO-03 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

314 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

314 participants in 2 patient groups

Experimental Arm (A)
Experimental group
Description:
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).
Treatment:
Radiation: Radiochemotherapy
Radiation: Intraoperative radiotherapy
Drug: Temozolomide
Procedure: Standard surgery
Control Arm (B)
Active Comparator group
Description:
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:
Radiation: Radiochemotherapy
Drug: Temozolomide
Procedure: Standard surgery

Trial contacts and locations

19

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Central trial contact

Clinical Trial Office UMM; Daniel Buergy, MD

Data sourced from clinicaltrials.gov

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