Clinical trial · Interventional
Radioimmunotherapy in Solid Tumors (PNRR-MCNT2-2023-12378239-Aim2)
Radioimmunotherapy in Solid Tumors (Aim 2- Stereotactic Neoadjuvant Radiotherapy for Glioblastoma)
- 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)
This is a prospective multicenter study of hypofractionated radiotherapy for the radiation treatment (RT) of solid tumors and in particular for Glioblastoma (in Aim 2). It is based on the results of ongoing studies at our Institute to validate the efficacy of extremely hypofractionated RT in neoadjuvant settings, which observed immunostimulatory effects of RT and the synergy with immune components. The collaboration between San Raffaele Hospital (Milan), the IRCCS Istituto Nazionale dei Tumori Fondazione G. Pascale (Naples) and the San Giuseppe Moscati Hospital of National Relief and High Specialty (Avellino) will ensure that patient recruitment, treatment and monitoring can be translated into facilities of the National Health System using common procedures. The various departments involved will treat patients with the same methods synergistically exploring the immuno/biological factors related to efficacy (and/or toxicity), based on new radioimmunotherapeutic approaches. Clinical and research activity will be developed jointly, drawing on the expertise in radiotherapy, radiomics, oncology, imaging and immunotherapy skills already available.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoaddjuvant Stereotactic Radiotherapy with Simultaneous Integrated Boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment arm
- description
- The 30 patients will receive neoadjuvant stereotactic radiotherapy in 5 fractions delivering 30 GY to PTV and 35-50 GY with Simultaneous Integrated Boost (SIB) to GTV using standard chemotherapy (TMZ) after surgery. GTV will be treated with escalating dose levels from 35 to 50 Gy. Patients will be divided into groups of 5 and will receive in the absence of 2 G4 toxicities per group, the following dose levels: 35-40-42.5-45-47.5 and 50 Gy
- interventionNames
- Radiation: Neoaddjuvant Stereotactic Radiotherapy with Simultaneous Integrated Boost
Primary outcomes (1)
- measure
- Acute toxicity
- timeFrame
- one month
- description
- Incidence of acute toxicity of grade 3 or 4 as maximum toxicity value during the radiation treatment or in any case within a month of the end of SBRT, using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scale (toxicity from 0- patients without toxicity to 5-death from toxicity)
Secondary outcomes (12)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of Glioblastoma. * ECOG performance score 0-2 (defined during the first visit) * Surgically removable lesion (according to the operability criteria established by the Neurosurgery Unit) For healthy volunteers, people who are as comparable as possible with the patient population in terms of sex and age will be recruited Exclusion Criteria: * Previous stroke * Presence of another primary and/or metastatic tumor For healthy volunteers also, absence of primary and/or metastatic tumor
References
Publications (34)
- RESULTThust SC, Heiland S, Falini A, Jager HR, Waldman AD, Sundgren PC, Godi C, Katsaros VK, Ramos A, Bargallo N, Vernooij MW, Yousry T, Bendszus M, Smits M. Glioma imaging in Europe: A survey of 220 centres and recommendations for best clinical practice. Eur Radiol. 2018 Aug;28(8):3306-3317. doi: 10.1007/s00330-018-5314-5. Epub 2018 Mar 13. PMID 29536240
- RESULTCastellano A, Falini A. Progress in neuro-imaging of brain tumors. Curr Opin Oncol. 2016 Nov;28(6):484-493. doi: 10.1097/CCO.0000000000000328. PMID 27649026
- RESULTWen PY, Macdonald DR, Reardon DA, Cloughesy TF, Sorensen AG, Galanis E, Degroot J, Wick W, Gilbert MR, Lassman AB, Tsien C, Mikkelsen T, Wong ET, Chamberlain MC, Stupp R, Lamborn KR, Vogelbaum MA, van den Bent MJ, Chang SM. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol. 2010 Apr 10;28(11):1963-72. doi: 10.1200/JCO.2009.26.3541. Epub 2010 Mar 15. PMID 20231676
- RESULTLaws ER, Parney IF, Huang W, Anderson F, Morris AM, Asher A, Lillehei KO, Bernstein M, Brem H, Sloan A, Berger MS, Chang S; Glioma Outcomes Investigators. Survival following surgery and prognostic factors for recently diagnosed malignant glioma: data from the Glioma Outcomes Project. J Neurosurg. 2003 Sep;99(3):467-73. doi: 10.3171/jns.2003.99.3.0467. PMID 12959431
- RESULTBrown TJ, Brennan MC, Li M, Church EW, Brandmeir NJ, Rakszawski KL, Patel AS, Rizk EB, Suki D, Sawaya R, Glantz M. Association of the Extent of Resection With Survival in Glioblastoma: A Systematic Review and Meta-analysis. JAMA Oncol. 2016 Nov 1;2(11):1460-1469. doi: 10.1001/jamaoncol.2016.1373. PMID 27310651
- RESULTLacroix M, Abi-Said D, Fourney DR, Gokaslan ZL, Shi W, DeMonte F, Lang FF, McCutcheon IE, Hassenbusch SJ, Holland E, Hess K, Michael C, Miller D, Sawaya R. A multivariate analysis of 416 patients with glioblastoma multiforme: prognosis, extent of resection, and survival. J Neurosurg. 2001 Aug;95(2):190-8. doi: 10.3171/jns.2001.95.2.0190.