TTFields In Germany in routine clinical care

TTFields In GErmany in Routine clinical care (TIGER): the use of TTFields for newly diagnosed GBM patients in Germany in routine clinical care

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN14267833

Enrollment

1000

Registered

2017-08-08

Start date

2017-08-31

Completion date

Unknown

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Cancer Glioblastoma

Interventions

This is non-interventional study evaluating use of tumor-treating fields (TTFields) in newly diagnosed glioblastoma (GBM) patients in routine clinical care. TTFields help slow down or stop glioblastom

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed histologically confirmed GBM (WHO-Grade IV) 2. Patient within first 3 cycles of first-line tumor-specific maintenance chemotherapy 3. = 18 years of age 4. Clinical indication for TTFields treatment 5. Given informed consent for use and processing of data

Exclusion criteria

Exclusion criteria: 1. Present or planned pregnancy 2. Significant additional neurological disease (e.g. significantly increased intracerebral pressure (ICP) with a significant midline shift of the brain) 3. Active implanted medical device (e.g. deep brain stimulator) 4. Documented allergy to conductive hydrogel 5. Skull defect (e.g. missing bone with no replacement, bullet fragments in the skull)

Design outcomes

Primary

Measure	Time frame
1. Time to death of any cause (overall survival [OS]) from diagnosis is measured using the patient data from date of enrollment until the date of death from any cause 2. Number of TTFields treatment-related (serious adverse events) SAEs standardised to one year of FU is measured using the collection of SAEs during the follow-up period 3. Number of SAEs after start of TTFields treatment is measured using the collection of SAEs at the follow-up period 4. Time of usage (compliance) of TTFields treatment over time is measured using the treatment compliance report at the follow-up period 5. Time to first progression of GBM (progression-free survival [PFS]), defined within radiological and/or clinical/neurological assessment during routine clinical care in patients who started TTFields treatment at baseline from date of enrollment until the date of first progression of GBM 6. Changes in quality of life after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline is measured using the QoL questionnaires at months two and four after start of TTFields treatment 7. Patients' reason(s) for refusing TTFields is measured using a questionnaire at baseline	—

Measure

Time frame

1. Time to death of any cause (overall survival [OS]) from diagnosis is measured using the patient data from date of enrollment until the date of death from any cause 2. Number of TTFields treatment-related (serious adverse events) SAEs standardised to one year of FU is measured using the collection of SAEs during the follow-up period 3. Number of SAEs after start of TTFields treatment is measured using the collection of SAEs at the follow-up period 4. Time of usage (compliance) of TTFields treatment over time is measured using the treatment compliance report at the follow-up period 5. Time to first progression of GBM (progression-free survival [PFS]), defined within radiological and/or clinical/neurological assessment during routine clinical care in patients who started TTFields treatment at baseline from date of enrollment until the date of first progression of GBM 6. Changes in quality of life after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline is measured using the QoL questionnaires at months two and four after start of TTFields treatment 7. Patients' reason(s) for refusing TTFields is measured using a questionnaire at baseline

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Germany

Contacts

Public ContactDunja Kosanovic

tiger@cri-muc.eu+49 (0)89 990 1649 968

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026