NCT07616986

Brief Summary

Glioblastoma (GBM) remains aggressive despite standard therapy (surgery (CRET) + RT/CT). Over 40% of patients develop recurrence between surgery and pre-RT MRI, with median overall survival (OS) of 13.3m and 24.4m for patients with and without recurrence in pre-RT MRI, respectively. Reoperation is avoided as it delays adjuvant therapy. LITT offers a minimally invasive alternative that may:

  • Treat recurrence without delaying RT/CT
  • Potentially sensitize tumors to subsequent therapy This study tests if LITT can be practically integrated within the critical 1-week window between pre-RT MRI and radiotherapy initiation, maintaining the adjuvant schedule.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Feb 2026Jan 2028

First Submitted

Initial submission to the registry

November 24, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 6, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

November 24, 2025

Last Update Submit

May 28, 2026

Conditions

Glioblastoma (GBM)Glioblastoma - Category

Keywords

LITTLaser Interstitial Thermal Therapyultra-early recurrenceGMBGMB recurrenceGMB ultra-early recurrence

Outcome Measures

Primary Outcomes (1)

  • Rate of patients who successfully complete the planned treatment

    Proportion of CRET patients who successfully complete the planned treatment protocol without protocol violation, until the end of radiation therapy. A protocol violation is defined as any of the following: a delay of more than 7 days in the scheduled pre-RT MRI, LITT procedure, or RT initiation, or an interruption of RT due to a LITT-related event. The study teams aims to describe logistical and organizational difficulties (coordination of intraoperative MRI-availability, engineering support).

    from enrollment to the end of radiotherapy, an average of 8 weeks

Secondary Outcomes (14)

  • Complications of LITT

    from enrollment to the end of radiotherapy, an average of 8 weeks

  • Delay of Radiotherapy

    assessed the day of radiation start, ranging from 3 to 6 weeks after GBM resection

  • Use of steroids

    from enrollment to the end of radiotherapy, an average of 8 weeks

  • Evolution of radiation necrosis

    from enrollment to the end of radiotherapy, an average of 8 weeks

  • Evolution of target lesion

    from enrollment to the end of radiotherapy, an average of 8 weeks

  • +9 more secondary outcomes

Study Arms (3)

LITT Group

EXPERIMENTAL

Patients undergoing MR-guided Laser Interstitial Thermal Therapy (LITT) between pre-RT MRI and RT

Device: LITT

Control Group 1 ("No recurrence")

NO INTERVENTION

Patients with no recurrence on pre-RT MRI, proceeding directly to RT.

Control Group 2 ("No LITT")

NO INTERVENTION

Patients with recurrence but ineligible for LITT, proceeding to another resection or to RT without laser therapy.

Interventions

LITTDEVICE

Patients undergoing MR-guided Laser Interstitial Thermal Therapy (LITT) between pre-RT MRI and RT.

LITT Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed glioblastoma, IDH-wildtype, regardless of MGMT status
  • ≥18 years of age
  • CRET
  • Karnofsky Performance Status (KPS) ≥70
  • No contra-indication for radio-chemotherapy
  • Scheduled for adjuvant radio-chemotherapy at University Hospital of Bern
  • Able to provide informed consent
  • No contra-indication for LITT
  • No pregnancy or active breast-feeding
  • No known coagulopathy independent of medication
  • No dissemination or multifocal disease
  • Patients lacking capacity to consent or considered vulnerable (e.g., minors, those under legal protection) are not included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Neurosurgery, Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

Related Publications (8)

  • Terrapon APR, Zattra CM, Voglis S, Velz J, Vasella F, Akeret K, Held U, Schiavolin S, Bozinov O, Ferroli P, Broggi M, Sarnthein J, Regli L, Neidert MC. Adverse Events in Neurosurgery: The Novel Therapy-Disability-Neurology Grade. Neurosurgery. 2021 Jul 15;89(2):236-245. doi: 10.1093/neuros/nyab121.

    PMID: 33887774BACKGROUND

  • Schaff LR, Mellinghoff IK. Glioblastoma and Other Primary Brain Malignancies in Adults: A Review. JAMA. 2023 Feb 21;329(7):574-587. doi: 10.1001/jama.2023.0023.

    PMID: 36809318BACKGROUND

  • Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.

    PMID: 15758009BACKGROUND

  • Waqar M, Roncaroli F, Lehrer EJ, Palmer JD, Villanueva-Meyer J, Braunstein S, Hall E, Aznar M, De Witt Hamer PC, D'Urso PI, Trifiletti D, Quinones-Hinojosa A, Wesseling P, Borst GR. Rapid early progression (REP) of glioblastoma is an independent negative prognostic factor: Results from a systematic review and meta-analysis. Neurooncol Adv. 2022 Jun 4;4(1):vdac075. doi: 10.1093/noajnl/vdac075. eCollection 2022 Jan-Dec.

    PMID: 35769410BACKGROUND

  • McGrath K, Frain M, Hey G, Rahman M. Complications following laser interstitial thermal therapy: a review. Neurochirurgie. 2025 Jan;71(1):101604. doi: 10.1016/j.neuchi.2024.101604. Epub 2024 Oct 23.

    PMID: 39413572BACKGROUND

  • Rangwala HS, Shafique MA, Mustafa MS, Kumar R, Devi J, Rangwala BS, Ali SMS, Raja A, Iqbal J, Ali M, Haseeb A. Evaluating efficacy and safety of laser interstitial thermal therapy in patients with newly diagnosed and recurrent glioblastoma: a systematic review and meta-analysis. Neurosurg Rev. 2024 Nov 12;47(1):846. doi: 10.1007/s10143-024-03077-6.

    PMID: 39528836BACKGROUND

  • Yu JS, Meade SM, Zhao R, Wei W, Dashora H, Prayson R, Grabowski MM, Stevens G, Lobbous M, Murphy ES, Suh JH, Chao ST, Barnett GH, Peereboom D, Ahluwalia MS, Mohammadi AM. Expedited chemoradiation after laser interstitial thermal therapy (LITT) is feasible and safe in patients with newly diagnosed glioblastoma. Neurooncol Adv. 2025 Feb 14;7(1):vdaf038. doi: 10.1093/noajnl/vdaf038. eCollection 2025 Jan-Dec.

    PMID: 40276375BACKGROUND

  • Hani L, Hakim A, Gehrig L, Staruch M, Goldberg J, Russli S, Soll N, Raabe A, Ermis E, Schucht P. Identification and relevance of ultra-early progression after resection of glioblastoma. J Neurosurg. 2025 Jul 25;143(5):1315-1324. doi: 10.3171/2025.3.JNS242212. Print 2025 Nov 1.

    PMID: 40712164BACKGROUND

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Philippe Schucht, MD

    Inselspital Bern, Department of Neurosurgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Schucht, MD

CONTACT

+41 31 632 00 14philippe.schucht@insel.ch

Alexis P. R. Terrapon, MD

CONTACT

+41 31 66 4 02 39alexis.terrapon@insel.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2025

First Posted

June 1, 2026

Study Start

February 6, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

January 31, 2028

Last Updated

June 1, 2026

Record last verified: 2026-05

Locations

CH(1)