GlioblastomaPhase 2RESURGENCT02394626
Surgery for Recurrent Glioblastoma
A Phase 2 study testing Surgery followed by adjuvant second-line therapy and Second-line therapy alone in people with Glioblastoma, run by Insel Gruppe AG, University Hospital Bern at 25 sites in 9 countries.
Trial summary
Patients with glioblastoma face a grim prognosis. Despite recent advancement in neurosurgical technology and neuro-oncology glioblastomas almost invariably progress or recur after a median of 4-8 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Surgery followed by adjuvant second-line therapy and Second-line therapy alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 25 sitesin 9 countries
- Study dates
- 1 May 2015to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- ≥18 years of age
- Prior resection of glioblastoma confirmed by histology
- Glioblastoma pretreated with standard radiotherapy without or with temozolomide
- First progression according to RANO criteria
- First progression not within 3 months after completion of radiation therapy
Show all 13Show fewer
- Complete removal of contrast-enhancing lesion considered feasible without significant risk of permanent speech or motor function according to MRI as confirmed by study eligibility committee after screening and prior to recruitment
- No encroachment of the M1 or A1 segments of the medial and anterior cerebral artery on MRI
- No contrast enhancement in presumed speech and primary motor areas on MRI
- No midline shift on MRI
- No contrast enhancing ventricular spread, multifocal recurrence, meningeosis carcinomatosa or infiltration of the contra-lateral hemisphere on MRI
- No contra-indication for surgery
- Good functional status (KPS ≥ 70)
Who cannot join
None listed.
Trial locations and contacts
25 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 9 countries
France8 sites, 8 recruiting
- Recruiting
Centre Hospitalier Universitaire Dijon Bourgogne, Department of Neurosurgery
Dijon
Tuan Le Van, +33 380293752, tuan.le-van@chu-dijon.fr
- Recruiting
Hospices Civils de Lyon - CHU de Lyon, Department of Neuro-Oncology
Lyon
Francois Ducray, +33478866634, francois.ducray@chu-lyon.fr
- Recruiting
Assistance Publique - Hôpitaux de Marseille, Department of Neuro-Oncology
Marseille
Emeline Tabouret, +33 4 91 38 55 00, Emeline.TABOURET@ap-hm.fr
- Recruiting
Centre Hospitalier Universitaire de Nice, Department of Neurosurgery
Nice
Fabien Almairac, +33492038450, almairac.f@chu-nice.fr
- Recruiting
Assistance Publique - Hôpitaux de Paris (AP-HP), Department of Neurosurgery
Paris
Bertrand Mathon, +33 1 40 27 30 00, bertrand.mathon@aphp.fr
- Recruiting
Centre Hospitalier Universitaire de Saint-Étienne, Department of Neurosurgery
Saint-Etienne
Fanélie Barral-Clavel, +33 4 77 82 80 00, fanelie.barral-clavel@chu-st-etienne.fr
- Recruiting
Institut de Cancérologie Strasbourg Europe (ICANS), Department of Oncology
Strasbourg
Georges Noel, +33 3 68 76 67 67, g.noel@icans.eu
- Recruiting
Centre Hospitalier Régional et Universitaire de Tours (CHRU Tours), Department of Neurosurgery
Tours
Ilyess Zemmoura, +33 2 47 47 47 47, ilyess.zemmoura@univ-tours.fr
Switzerland4 sites, 4 recruiting
- Recruiting
Universitätsspital Basel
Basel, 4031
Dominik Cordier, dominik.cordier@usb.ch
- Recruiting
Dep. of Neurosurgery, Bern University Hospital
Bern, 3010
Philippe Schucht
- Recruiting
Dep. of Neurosurgery, Centre hospitalier universitaire vaudois
Lausanne, 1011
Andreas Hottinger, MD, andreas.hottinger@chuv.ch
Andreas Hottinger
- Recruiting
Ospedale Regionale di Lugano
Lugano, 6900
Francesco Marchi, MD, francesco.marchi@eoc.ch
Austria3 sites, 3 recruiting
- Recruiting
Universitätsklinikum Innsbruck
Innsbruck
Christian Freyschlag, MD, christian.freyschlag@tirol-kliniken.at
Johannes Kerschbaumer, MD, Johannes.kerschbaumer@tirol-kliniken.at
- Recruiting
Johannes Kepler University Linz University, Clinic for Neurosurgery
Linz
Andreas Gruber, +43 732 2468 0, andreas.gruber_1@kepleruniklinikum.at
- Recruiting
Medical University of Vienna, Department of Neurosurgery
Vienna
Barbara Kiesel, MD, +43 1 40400-45650, barbara.kiesel@meduniwien.ac.at
Netherlands3 sites, 3 recruiting
- Recruiting
Department of Neurosurgery, Amsterdam University Medical Center
Amsterdam
Philip de Witt Hamer, MD, p.dewitthamer@amsterdamumc.nl
- Recruiting
Department of Neurosurgery, Radboud University Medical Center, Nijmegen
Nijmegen
Mark ter Laan, MD, mark.terlaan@radboudumc.nl
- Recruiting
Department of Neurosurgery, Haaglanden Medical Center, The Hague
The Hague
Marike Broekman, MD, m.broekman@haaglandenmc.nl
Germany2 sites, 2 recruiting
- Recruiting
Helios Klinikum Erfurt
Erfurt, 99089
Rüdiger Gerlach, MD, ruediger.gerlach@helios-gesundheit.de
- Recruiting
Universitätsklinikum Münster
Münster, 48149
Benjamin Brokinkel, benjamin.brokinkel@ukmuenster.de
Sweden2 sites, 2 recruiting
- Not yet recruiting
University of Gothenburg, Department of Clinical Neuroscience
Gothenburg
Jakola Asgeir, +46 31-786 00 00, jakola.asgeir@gu.se
- Not yet recruiting
University Hospital of Umeå, Department of Diagnostics and Intervention
Umeå
Maria Sandström, +46 90 785 00 00, maria.sandstrom@umu.se
Greece1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, Hospital of Larissa & General Hospital of Larissa
Larissa, 412 21
Kostas Fountas, MD, fountas@med.uth.gr
Portugal1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria
Lisbon, 1649-035
Alexandre Rainha Campos, MD
Spain1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, L'Hospitalet de Llobregat, Barcelona
Barcelona
Gerard Plans, MD, gplans@bellvitgehospital.cat
About this study
Official title: RESURGE - Randomized Controlled Comparative Phase II Trial on Surgery for Glioblastoma Recurrence
Patients with glioblastoma face a grim prognosis. Despite recent advancement in neurosurgical technology and neuro-oncology glioblastomas almost invariably progress or recur after a median of 4-8 months. The strategy to repeat tumor resection at recurrence in order to minimize tumor load and thus to facilitate subsequent second-line therapy has been shown to be feasible and safe.
However, evidence for a survival benefit of surgery for recurrent glioblastoma is scarce and relies entirely on retrospective analyses. While most retrospective analyses report an apparent survival benefit, an EORTC meta-analysis on second-line therapies found no survival difference in patients with or without surgery at recurrence. With regard to the risks and costs inherent to surgery for glioblastoma, a randomized controlled trial is required.
The purpose of the study is to compare the effect of craniotomy and tumor resection followed by adjuvant second-line therapy to no surgery followed by second-line therapy on overall survival, neurological status, and quality of life. Analysis of overall survival will be used to improve sample size estimation of a subsequent phase III trial for craniotomy and tumor resection of glioblastoma recurrence in cooperation with the EORTC.
Read the detailed description
Background
Glioblastoma is a malignant, locally invasive brain tumor whose prognosis remains grim despite various intense treatment modalities. In the past, radical surgery was met with skepticism due to the aggressive infiltrative character of the tumor. However, an increasing number of retrospective studies over the last decade suggest a survival benefit for surgery. A recent post-hoc analysis of a randomized controlled trial on the use of the surgical adjunct 5-ALA reported a prolonged overall survival from 11.9 to 16.7 months (evidence level 2a) after more extensive resection. Thus, maximal safe resection has become a mainstay of treatment for newly diagnosed glioblastoma, followed by adjuvant radio-chemotherapy.
Glioblastoma almost invariably recurs after a median of 6.9 months, leaving but few options for further treatment. Recurrence of glioblastoma after surgery and concomitant adjuvant therapy represents an additional therapeutic challenge and may be treated with second-line pharmacotherapy. In addition, a second surgery may also be considered in highly selected patients.
The rationale for surgery - maximum safe resection - is to prolong survival through reduction of tumor load, and, maybe due to an increased efficacy of adjuvant treatment. However, surgery carries risks of complications, that may result in a decreased functional and survival outcome. The crucial question therefore is whether, to what extent, and at what costs in terms of neurological risks a second resection prolongs survival.
Objective
The primary objective of this randomized trial is to compare survival outcome after surgery followed by adjuvant second-line therapy to no surgery followed by second-line therapy in recurrent glioblastoma. An auxiliary objective to primary objective is to compare the survival outcomes of operated patients to control in the subgroups stratified by extent of resection: incomplete resection (non-CRET) vs complete resection (CRET).
Secondary objectives are: assessment of recruitment for all screened patients, comparison of progression-free survival between treatment arms, evaluation of crossover and comparison of patient quality of life between treatment arms.
Safety objectives are: to assess neurological deficits, local infections and morbidity associated to surgery and hospital stay after surgery and during follow-up.
Methods
All patients (≥18 years) with a radiological suspicion of first recurrence of glioblastoma are screened for this trial. Patients eligible for study participation are informed on the treatment options for recurrent glioblastoma (surgery followed by adjuvant second-line therapy, second-line therapy, or palliative therapy alone) by the center investigators. Patients randomized to the control group will receive second-line therapy according to local guidelines. Patients randomized to the interventional group will receive a craniotomy and resection of the tumor followed by adjuvant second-line therapy. Outcome will be measured at 3 months intervals.
Recruitment rate and reason for non-inclusion will be monitored.
- Conditions
- Glioblastoma
- Being tested
- Surgery followed by adjuvant second-line therapy, Second-line therapy alone
- Keywords
- Recurrent glioblastoma, Surgery, Complete resection of enhancing tumor, Survival, Quality of life
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery followed by adjuvant second-line therapyProcedure or surgery
Surgery:
Surgery must take place between day 1 and 14 after study inclusion and within 21 days from the MRI on which recurrence was diagnosed. The modalities of surgery and the choice of pre- and intra-operative technical adjuncts is at the treating neurosurgery discretion. Surgery must take place between day 1 and 14 after study inclusion and within 21 days from the MRI on which recurrence was diagnosed. The modalities of surgery and the choice of pre- and intra-operative technical adjuncts is at the treating neurosurgery discretion. However, some form of intra-operative resection control (iMRI or intra-operative fluorescence) and function control (electrophysiology) should be available to the surgeon and used when warranted.
Adjuvant second-line therapy:
Patients will be seen after surgery by the treating neurooncologist. Modalities of adjuvant second-line therapy are individually defined according to local guidelines and are not stipulated by study protocol.
Second-line therapy aloneProcedure or surgery
Patients randomized to the non-surgical cohort receive second-line therapy according to local guidelines. Modalities thereof are not stipulated by study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Surgery followed by adjuvant second-line therapy | Experimental | Surgery followed by adjuvant second-line therapy Receives: Procedure: Surgery followed by adjuvant second-line therapy |
| Second-line therapy alone | Active comparator | Second-line therapy alone Receives: Procedure: Second-line therapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival from the date of inclusion
Measured: From the date of inclusion until death/end of study, assessed up to 5.7 years
Secondary outcomes (5)
Recruitment rate for all screened patients
Measured: Screening and inclusion
Progression-free survival
Measured: From the date of inclusion until the date of objective progression or the date of patient's death, whichever occurs first, assessed up to 5.7 years
Morbidity of surgery
Measured: Every 3 months up to 2 years or until death, assessed up to 5.7 years
Total number of days spent at home after recurrence
Measured: From the date of inclusion until death/end of study, assessed up to 5.7 years
Total number of days spent outside home after recurrence
Measured: From the date of inclusion until death/end of study, assessed up to 5.7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study start1 May 2015
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Schucht, Prof. Dr. med., Principal investigator, Dep. of Neurosurgery, Inselspital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394626
- Sponsor's protocol ID
- 368/14
- Acronym
- RESURGE
- Status last verified
- Jan 2026
- First submitted
- 11 Mar 2015
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESURGE - Randomized Controlled Comparative Phase II Trial on Surgery for Glioblastoma Recurrence
- ClinicalTrials.gov ID
- NCT02394626
- Acronym / sponsor ID
- RESURGE / 368/14
- Conditions
- Glioblastoma
- Keywords
- Recurrent glioblastoma, Surgery, Complete resection of enhancing tumor, Survival, Quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC
- Study start
- 1 May 2015 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with glioblastoma face a grim prognosis. Despite recent advancement in neurosurgical technology and neuro-oncology glioblastomas almost invariably progress or recur after a median of 4-8 months. The strategy to repeat tumor resection at recurrence in order to minimize tumor load and thus to facilitate subsequent second-line therapy has been shown to be feasible and safe.
However, evidence for a survival benefit of surgery for recurrent glioblastoma is scarce and relies entirely on retrospective analyses. While most retrospective analyses report an apparent survival benefit, an EORTC meta-analysis on second-line therapies found no survival difference in patients with or without surgery at recurrence. With regard to the risks and costs inherent to surgery for glioblastoma, a randomized controlled trial is required.
The purpose of the study is to compare the effect of craniotomy and tumor resection followed by adjuvant second-line therapy to no surgery followed by second-line therapy on overall survival, neurological status, and quality of life. Analysis of overall survival will be used to improve sample size estimation of a subsequent phase III trial for craniotomy and tumor resection of glioblastoma recurrence in cooperation with the EORTC.
Detailed description
Background
Glioblastoma is a malignant, locally invasive brain tumor whose prognosis remains grim despite various intense treatment modalities. In the past, radical surgery was met with skepticism due to the aggressive infiltrative character of the tumor. However, an increasing number of retrospective studies over the last decade suggest a survival benefit for surgery. A recent post-hoc analysis of a randomized controlled trial on the use of the surgical adjunct 5-ALA reported a prolonged overall survival from 11.9 to 16.7 months (evidence level 2a) after more extensive resection. Thus, maximal safe resection has become a mainstay of treatment for newly diagnosed glioblastoma, followed by adjuvant radio-chemotherapy.
Glioblastoma almost invariably recurs after a median of 6.9 months, leaving but few options for further treatment. Recurrence of glioblastoma after surgery and concomitant adjuvant therapy represents an additional therapeutic challenge and may be treated with second-line pharmacotherapy. In addition, a second surgery may also be considered in highly selected patients.
The rationale for surgery - maximum safe resection - is to prolong survival through reduction of tumor load, and, maybe due to an increased efficacy of adjuvant treatment. However, surgery carries risks of complications, that may result in a decreased functional and survival outcome. The crucial question therefore is whether, to what extent, and at what costs in terms of neurological risks a second resection prolongs survival.
Objective
The primary objective of this randomized trial is to compare survival outcome after surgery followed by adjuvant second-line therapy to no surgery followed by second-line therapy in recurrent glioblastoma. An auxiliary objective to primary objective is to compare the survival outcomes of operated patients to control in the subgroups stratified by extent of resection: incomplete resection (non-CRET) vs complete resection (CRET).
Secondary objectives are: assessment of recruitment for all screened patients, comparison of progression-free survival between treatment arms, evaluation of crossover and comparison of patient quality of life between treatment arms.
Safety objectives are: to assess neurological deficits, local infections and morbidity associated to surgery and hospital stay after surgery and during follow-up.
Methods
All patients (≥18 years) with a radiological suspicion of first recurrence of glioblastoma are screened for this trial. Patients eligible for study participation are informed on the treatment options for recurrent glioblastoma (surgery followed by adjuvant second-line therapy, second-line therapy, or palliative therapy alone) by the center investigators. Patients randomized to the control group will receive second-line therapy according to local guidelines. Patients randomized to the interventional group will receive a craniotomy and resection of the tumor followed by adjuvant second-line therapy. Outcome will be measured at 3 months intervals.
Recruitment rate and reason for non-inclusion will be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery followed by adjuvant second-line therapy | Experimental | Procedure: Surgery followed by adjuvant second-line therapySurgery followed by adjuvant second-line therapy |
| Second-line therapy alone | Active comparator | Procedure: Second-line therapy aloneSecond-line therapy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent
- ≥18 years of age
- Prior resection of glioblastoma confirmed by histology
- Glioblastoma pretreated with standard radiotherapy without or with temozolomide
- First progression according to RANO criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery followed by adjuvant second-line therapySurgery: Surgery must take place between day 1 and 14 after study inclusion and within 21 days from the MRI on which recurrence was diagnosed. The modalities of surgery and the choice of pre- and intra-operative technical adjuncts is at the treating neurosurgery discretion. Surgery must take place between day 1 and 14 after study inclusion and within 21 days from the MRI on which recurrence was diagnosed. The modalities of surgery and the choice of pre- and intra-operative technical adjuncts is at the treating neurosurgery discretion. However, some form of intra-operative resection control (iMRI or intra-operative fluorescence) and function control (electrophysiology) should be available to the surgeon and used when warranted. Adjuvant second-line therapy: Patients will be seen after surgery by the treating neurooncologist. Modalities of adjuvant second-line therapy are individually defined according to local guidelines and are not stipulated by study protocol. | Procedure or surgery | Surgery followed by adjuvant second-line therapy |
| Second-line therapy alonePatients randomized to the non-surgical cohort receive second-line therapy according to local guidelines. Modalities thereof are not stipulated by study protocol. | Procedure or surgery | Second-line therapy alone |
Primary outcome
Overall survival from the date of inclusion
Time frame: From the date of inclusion until death/end of study, assessed up to 5.7 years
5 secondary outcomes
Recruitment rate for all screened patients
Time frame: Screening and inclusion
Progression-free survival
Time frame: From the date of inclusion until the date of objective progression or the date of patient's death, whichever occurs first, assessed up to 5.7 years
Morbidity of surgery
Time frame: Every 3 months up to 2 years or until death, assessed up to 5.7 years
Total number of days spent at home after recurrence
Time frame: From the date of inclusion until death/end of study, assessed up to 5.7 years
Total number of days spent outside home after recurrence
Time frame: From the date of inclusion until death/end of study, assessed up to 5.7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philippe Schucht, Prof. Dr. med. principal investigator
Dep. of Neurosurgery, Inselspital Bern
25 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surgery followed by adjuvant second-line therapy and Second-line therapy alone in people with Glioblastoma, run by Insel Gruppe AG, University Hospital Bern at 25 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France, Switzerland, Austria, Netherlands, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Schucht, MD (+41 31 66 4 28 65, resurge@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival from the date of inclusion (time frame: From the date of inclusion until death/end of study, assessed up to 5.7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.