Glioblastoma Multiforme (GBM)Phase 1/2PriCoTTFNCT07120620
PriCoTTF Study: TTFields Before and During Radiotherapy for Newly Diagnosed Glioblastoma
A Phase 1/2 study testing TTFields before and during radiotherapy in people with Glioblastoma Multiforme (GBM), run by Sied Kebir at 1 site in Germany.
Trial summary
The PriCoTTF clinical trial is related to the development and validation of the investigational product Optune®, a device for generating tumor therapy fields (TTFields) that is used in combination with radiation therapy to treat newly diagnosed glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme (GBM)
- What is being tested?
- TTFields before and during radiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jun 2019to 28 Aug 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- At least 18 years of age
- Pathological evidence of glioblastoma or gliosarcoma using latest World Health Organization (WHO) classification criteria
- Negative isocitrate dehydrogenase (IDH) status on immunohistochemistry or sequencing
- Patient received brain tumor resection or biopsy and further treatment regime foresees radiotherapy with or without concomitant chemotherapy
- General indication for whole treatment regimen was a common decision of a multidisciplinary team within brain tumor board and in accordance with the national and/or international guidelines for the treatment of glioblastoma patients
- KPS ≥ 60% (Study arm A), KPS ≥ 50% (Study arm B)
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- Life expectancy at least 3 months
- Participants of child-bearing age must use effective contraception
- Treatment with Tumor Treating Fields (TTFields) may start 2-4 weeks post resection and 1-2 weeks prior to radiotherapy
- Subjects with the ability to follow study instructions and likely to attend and complete all required visits
- Written informed consent of the subject
Who cannot join
- General Exclusion Criteria:
- Subjects not able to give consent
- Subject without legal capacity who is unable to understand the nature, scope, significance, and consequences of this clinical trial
- Simultaneously participation in another clinical trial or participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
- Subjects with a physical or psychiatric condition which at the investigator´s discretion may put the subject at risk, may confound the trial results or may interfere with the subject's participation in this clinical trial
- Known or persistent abuse of medication, drugs or alcohol
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- Exclusion criteria regarding special restrictions for females:
- Current or planned pregnancy or nursing women
- Females of child-bearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
- Indication-specific exclusion criteria:
- Infra-tentorial tumor
- Significant comorbidities at baseline, which would prevent possible chemotherapy, including:
- Platelet count < 100/nl
- Absolute neutrophil count (ANC) < 1.5/nl
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal
- Total bilirubin above the normal range
- Serum creatinine > 1.7 mg/dl
- Patients with clinically significant liver-, renal- or blood disorder
- Patients with known additional significant neurological disease (e.g. primary seizure disorder*, dementia, progressive degenerative neurological disease, meningitis or encephalitis, hydrocephalus with increased intracranial pressure)
- Patients with brain tumor-related epilepsy, seizure-free under antiepileptic therapy are eligible
- Documented allergy to conductive hydrogel (e.g. ECG (electrocardiogram) sticker or TENS (transcutaneous electrical nerve stimulation) electrodes
- Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators and programmable shunts)or documented clinically significant arrhythmias
- Skull defect (e.g. missing bone with no replacement) and bullet fragments in the skull
- History of hypersensitivity reaction to temozolomide or lomustine
- Positive human immunodeficiency virus (HIV) Test
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Essen, Department of Neurology, Division of Clinical Neuro-Oncology
Essen, Northrhine-Westfalia, 45147
About this study
Official title: PriCoTTF Study: A Phase I/II Study With TTFields Before and During Radiotherapy in Newly Diagnosed Glioblastoma
The PriCoTTF clinical trial is related to the development and validation of the investigational product Optune®, a device for generating tumor therapy fields (TTFields) that is used in combination with radiation therapy to treat newly diagnosed glioblastoma. The trial aims to evaluate the safety of early and concurrent use of TTFields with standard radiation chemotherapy. This strategy is based on preclinical data suggesting that TTFields increase the sensitivity of tumor cells to radiation therapy. Critical components of this clinical trial include demonstrating the safety and tolerability of TTFields in combination with radiation therapy and collecting initial efficacy data. The target population consists of patients with newly diagnosed glioblastoma, with treatment beginning immediately after surgical resection and continuing for up to nine months. Follow-up examinations will be conducted at regular intervals to monitor long-term treatment success. The trial protocol was developed in accordance with the guidelines of the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP). In addition, discussions were held between the sponsor, Essen University Hospital, and the relevant regulatory authorities to ensure that the clinical trial complies with regulatory requirements and is ethically acceptable. Compliance with these standards ensures scientific validity and patient safety throughout the study.
- Conditions
- Glioblastoma Multiforme (GBM)
- Being tested
- TTFields before and during radiotherapy
- Keywords
- newly-diagnosed glioblastoma, TTFields, Tumor Treating Fields, radiotherapy, chemotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTFields before and during radiotherapyDevice
Administration of TTFields before and during radiation therapy in patients with primary glioblastoma (Arm A)
TTFields before and during radiotherapyDevice
Administration of TTFields before and during radiation therapy in patients with primary glioblastoma (Arm B)
| Study group | Role | What they receive |
|---|---|---|
| Arm A: surgery, TTFields, radiotherapy and chemotherapy | Experimental | Following diagnosis of primary glioblastoma, patients are treated with postsurgical TTFields (2-4 weeks after surgery and 1-2 weeks prior radiotherapy) followed by TTFields concomitant to radiotherapy (60 Gy will be given in 30 fractions with 2 Gy per fraction). Concomitant and adjuvant chemotherapy will be administered according to institutional standards and interdisciplinary tumor conference. Receives: Device: TTFields before and during radiotherapy |
| Arm B: Surgery, TTFields, hypofractional radiotherapy, chemotherapy (if applicable) | Experimental | Following diagnosis of primary glioblastoma, patients are treated with postsurgical TTFields (2-4 weeks after surgery and 1-2 weeks prior radiotherapy) followed by TTFields concomitant to radiotherapy for 3 weeks (40 Gy will be given at 2,67 Gy per daily fraction). Chemotherapy will be administered according to institutional standards and interdisciplinary tumor conference. Receives: Device: TTFields before and during radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and safety (frequency of predefined treatment-limiting toxicities (TLTs)) of Tumor Treating Fields (TTFields) before and concurrently with radiation therapy in patients with primary glioblastoma
The primary endpoint is safety and tolerability. It is based on the frequency of predefined treatment-limiting toxicities (TLTs), which are assessed weekly during therapy and up to four weeks after the end of radiation therapy.
Measured: From the day of surgery until 4 weeks after end of radiotherapy (usually 10-12 weeks)
Secondary outcomes (10)
Long-term treatment-limiting toxicities (TLTs)
TLT 4 weeks after radiotherapy completion until the end of treatment or tumor recurrence, whichever occurs first (overall and considering concomitant chemotherapy)
Measured: Until the end of treatment or tumor recurrence, whichever occurs first (usually 6 to 24 months)
Short-term treatment-limiting toxicities (TLTs)
TLT during treatment and up to 4 weeks after end of radiotherapy concomitant chemotherapy
Measured: During (usually 3-6 weeks) radiotherapy and up to 4 weeks after the end of radiotherapy
Progession free survival (PFS)
Time from diagnosis to MRI based tumor progression
Measured: Until tumor recurrence (usually 6 to 12 months)
Overall survival (OS)
Overall survival from diagnosis to death
Measured: From tumor diagnosis to death (usually 6 to 24 months)
Radiological response (RANO criteria)
The radiological response is assessed during regular MRI follow-up examinations.
Measured: Until the end of treatment or tumor recurrence, whichever occurs first (usually 6 to 24 months)
Adverse events as measured by Common Terminology Criteria for Adverse Events (CTCAE)
Adverse events are classified according to CTCAE
Measured: Until the end of treatment or tumor recurrence, whichever occurs first (usually 6 to 24 months)
Quality of life (QoL)
The following questionnaires are used to assess quality of life:
EORTC Core Quality of Life Questionnaire [QLQ-C30], (Part A with 28 questions on a Likert scale, 28 to 112 points, Higher score means lower quality of life; Part B with 2 questions on a Likert scale, 2 to 14 points, Lower score means lower quality of life)
EORTC Brain Questionaire [QLQ-BN20], (20 questions on a Likert scale; 20 to 80 points; Higher score means lower quality of life)
Measured: At end of radiotherapy (usually 3-10 weeks after randomization); 4 weeks after the end of radiotherapy; at 3, 5 and 7 months of TTFields treatment
Estimation number of fully compliant patients
Fully compliant is defined as: Wearing rate of TTFields must be at least 50% between randomisation and visit 4 (4 weeks after the end of radiotherapy).
Measured: Usually 7 to 12 weeks
Estimation of the delivered cumulative dose distribution
Estimation of the delivered cumulative dose distribution over the treatment series for each patient from the KV-image guidance data and comparison with the planned dose distribution. Dose deviations by more than 3.5% in more than 1 cm3 within the PTV or if more than 5% in less than 1 cm3 will be considered as relevant
Measured: From beginning to the end of radiotherapy (usually 3-6 weeks)
Number of patients with ≥ grade 3 skin toxicity (Common Terminology Criteria for Adverse Events, CTCAE)
Number of patients with ≥ grade 3 skin toxicity (CTCAE) separately into patients with high 1 and low radiation risk. 1: high risk group: patients who received a surface dose >70% of the prescribed dose within or up to 6 mm below the skin on a scalp area are of >50 cm2
Measured: Until the end of treatment or tumor recurrence, whichever occurs first (usually 6 to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start25 Jun 2019
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma Multiforme (GBM)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sied Kebir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sied Kebir, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120620
- Sponsor's protocol ID
- EXT-201701
- Acronym
- PriCoTTF
- Status last verified
- Aug 2025
- First submitted
- 16 Jun 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PriCoTTF Study: A Phase I/II Study With TTFields Before and During Radiotherapy in Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT07120620
- Acronym / sponsor ID
- PriCoTTF / EXT-201701
- Conditions
- Glioblastoma Multiforme (GBM)
- Keywords
- newly-diagnosed glioblastoma, TTFields, Tumor Treating Fields, radiotherapy, chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Sied KebirUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 13 Aug 2025 (actual)
- 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.
The PriCoTTF clinical trial is related to the development and validation of the investigational product Optune®, a device for generating tumor therapy fields (TTFields) that is used in combination with radiation therapy to treat newly diagnosed glioblastoma. The trial aims to evaluate the safety of early and concurrent use of TTFields with standard radiation chemotherapy. This strategy is based on preclinical data suggesting that TTFields increase the sensitivity of tumor cells to radiation therapy. Critical components of this clinical trial include demonstrating the safety and tolerability of TTFields in combination with radiation therapy and collecting initial efficacy data. The target population consists of patients with newly diagnosed glioblastoma, with treatment beginning immediately after surgical resection and continuing for up to nine months. Follow-up examinations will be conducted at regular intervals to monitor long-term treatment success. The trial protocol was developed in accordance with the guidelines of the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP). In addition, discussions were held between the sponsor, Essen University Hospital, and the relevant regulatory authorities to ensure that the clinical trial complies with regulatory requirements and is ethically acceptable. Compliance with these standards ensures scientific validity and patient safety throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: surgery, TTFields, radiotherapy and chemotherapy | Experimental | Device: TTFields before and during radiotherapyFollowing diagnosis of primary glioblastoma, patients are treated with postsurgical TTFields (2-4 weeks after surgery and 1-2 weeks prior radiotherapy) followed by TTFields concomitant to radiotherapy (60 Gy will be given in 30 fractions with 2 Gy per fraction). Concomitant and adjuvant chemotherapy will be administered according to institutional standards and interdisciplinary tumor conference. |
| Arm B: Surgery, TTFields, hypofractional radiotherapy, chemotherapy (if applicable) | Experimental | Device: TTFields before and during radiotherapyFollowing diagnosis of primary glioblastoma, patients are treated with postsurgical TTFields (2-4 weeks after surgery and 1-2 weeks prior radiotherapy) followed by TTFields concomitant to radiotherapy for 3 weeks (40 Gy will be given at 2,67 Gy per daily fraction). Chemotherapy will be administered according to institutional standards and interdisciplinary tumor conference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- At least 18 years of age
- Pathological evidence of glioblastoma or gliosarcoma using latest World Health Organization (WHO) classification criteria
- Negative isocitrate dehydrogenase (IDH) status on immunohistochemistry or sequencing
- Patient received brain tumor resection or biopsy and further treatment regime foresees radiotherapy with or without concomitant chemotherapy
- General indication for whole treatment regimen was a common decision of a multidisciplinary team within brain tumor board and in accordance with the national and/or international guidelines for the treatment of glioblastoma patients
Key exclusion criteria (25 listed)
- Subjects not able to give consent
- Subject without legal capacity who is unable to understand the nature, scope, significance, and consequences of this clinical trial
- Simultaneously participation in another clinical trial or participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
- Subjects with a physical or psychiatric condition which at the investigator´s discretion may put the subject at risk, may confound the trial results or may interfere with the subject's participation in this clinical trial
- Known or persistent abuse of medication, drugs or alcohol
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 |
|---|---|---|
| TTFields before and during radiotherapyAdministration of TTFields before and during radiation therapy in patients with primary glioblastoma (Arm A) | Device | Arm A: surgery, TTFields, radiotherapy and chemotherapy |
| TTFields before and during radiotherapyAdministration of TTFields before and during radiation therapy in patients with primary glioblastoma (Arm B) | Device | Arm B: Surgery, TTFields, hypofractional radiotherapy, chemotherapy (if applicable) |
Primary outcome
Feasibility and safety (frequency of predefined treatment-limiting toxicities (TLTs)) of Tumor Treating Fields (TTFields) before and concurrently with radiation therapy in patients with primary glioblastoma
Time frame: From the day of surgery until 4 weeks after end of radiotherapy (usually 10-12 weeks)
The primary endpoint is safety and tolerability. It is based on the frequency of predefined treatment-limiting toxicities (TLTs), which are assessed weekly during therapy and up to four weeks after the end of radiation therapy.
10 secondary outcomes
Long-term treatment-limiting toxicities (TLTs)
Time frame: Until the end of treatment or tumor recurrence, whichever occurs first (usually 6 to 24 months)
Short-term treatment-limiting toxicities (TLTs)
Time frame: During (usually 3-6 weeks) radiotherapy and up to 4 weeks after the end of radiotherapy
Progession free survival (PFS)
Time frame: Until tumor recurrence (usually 6 to 12 months)
Overall survival (OS)
Time frame: From tumor diagnosis to death (usually 6 to 24 months)
Radiological response (RANO criteria)
Time frame: Until the end of treatment or tumor recurrence, whichever occurs first (usually 6 to 24 months)
Adverse events as measured by Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: Until the end of treatment or tumor recurrence, whichever occurs first (usually 6 to 24 months)
Quality of life (QoL)
Time frame: At end of radiotherapy (usually 3-10 weeks after randomization); 4 weeks after the end of radiotherapy; at 3, 5 and 7 months of TTFields treatment
Estimation number of fully compliant patients
Time frame: Usually 7 to 12 weeks
Estimation of the delivered cumulative dose distribution
Time frame: From beginning to the end of radiotherapy (usually 3-6 weeks)
Number of patients with ≥ grade 3 skin toxicity (Common Terminology Criteria for Adverse Events, CTCAE)
Time frame: Until the end of treatment or tumor recurrence, whichever occurs first (usually 6 to 24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TTFields before and during radiotherapy in people with Glioblastoma Multiforme (GBM), run by Sied Kebir at 1 site in Germany.
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 11 inclusion and 25 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: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and safety (frequency of predefined treatment-limiting toxicities (TLTs)) of Tumor Treating Fields (TTFields) before and concurrently with radiation therapy in patients with primary glioblastoma (time frame: From the day of surgery until 4 weeks after end of radiotherapy (usually 10-12 weeks)). 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 13 Aug 2025.