Clinical trial · Interventional
Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme
A Multicenter Randomized Phase III Trial on INTraoperative RAdiotherapy in Newly Diagnosed GliOblastoma Multiforme (INTRAGO II)
NCT02685605CI-TRIAL-00096549INTRAGO-IIactive not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative radiotherapy | Radiation | — | UNRESOLVED |
| Radiochemotherapy | Radiation | — | UNRESOLVED |
| Standard surgery | Procedure | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Arm (A)
- 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).
- interventionNames
- Procedure: Standard surgery
- Radiation: Intraoperative radiotherapy
- Radiation: Radiochemotherapy
- Drug: Temozolomide
- type
- ACTIVE_COMPARATOR
- label
- Control Arm (B)
- 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).
- interventionNames
- Procedure: Standard surgery
- Radiation: Radiochemotherapy
- Drug: Temozolomide
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDGiordano FA, Brehmer S, Abo-Madyan Y, Welzel G, Sperk E, Keller A, Schneider F, Clausen S, Herskind C, Schmiedek P, Wenz F. INTRAGO: intraoperative radiotherapy in glioblastoma multiforme-a phase I/II dose escalation study. BMC Cancer. 2014 Dec 22;14:992. doi: 10.1186/1471-2407-14-992. PMID 25535398
- BACKGROUNDSarria GR, Sperk E, Han X, Sarria GJ, Wenz F, Brehmer S, Fu B, Min S, Zhang H, Qin S, Qiu X, Hanggi D, Abo-Madyan Y, Martinez D, Cabrera C, Giordano FA. Intraoperative radiotherapy for glioblastoma: an international pooled analysis. Radiother Oncol. 2020 Jan;142:162-167. doi: 10.1016/j.radonc.2019.09.023. Epub 2019 Oct 16. PMID 31629553
- BACKGROUNDAyala Alvarez DS, Watson PGF, Popovic M, Heng VJ, Evans MDC, Panet-Raymond V, Seuntjens J. Evaluation of Dosimetry Formalisms in Intraoperative Radiation Therapy of Glioblastoma. Int J Radiat Oncol Biol Phys. 2023 Nov 1;117(3):763-773. doi: 10.1016/j.ijrobp.2023.04.031. Epub 2023 May 5. PMID 37150259
- BACKGROUNDCifarelli CP, Jacobson GM. Intraoperative Radiotherapy in Brain Malignancies: Indications and Outcomes in Primary and Metastatic Brain Tumors. Front Oncol. 2021 Nov 11;11:768168. doi: 10.3389/fonc.2021.768168. eCollection 2021. PMID 34858846
- BACKGROUNDSarria GR, Smalec Z, Muedder T, Holz JA, Scafa D, Koch D, Garbe S, Schneider M, Hamed M, Vatter H, Herrlinger U, Giordano FA, Schmeel LC. Dosimetric Comparison of Upfront Boosting With Stereotactic Radiosurgery Versus Intraoperative Radiotherapy for Glioblastoma. Front Oncol. 2021 Oct 28;11:759873. doi: 10.3389/fonc.2021.759873. eCollection 2021. PMID 34778080
- DERIVEDGiordano FA, Ganslandt O, Munter MW, Combs SE, Diehl C, Meyer B, Herrlinger U, Schneider M, Kahl KH, Shiban E, Goenka A, Schulder M, Lucas A, Plans G, Brehmer S, Ruder AM, Garcia-Cabezas S, Solivera J, Cifarelli CP, Wenz F, Sarria GR, Pope WB, Layer JP, Tsien CI, Petrecca K; INTRAGO-II Study Group. Dose escalation with intraoperative radiotherapy in newly diagnosed glioblastoma (INTRAGO-II): an open-label, multicentre, randomised, controlled, phase 3 trial. Lancet Oncol. 2026 Jul;27(7):864-878. doi: 10.1016/S1470-2045(26)00235-4.