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The CyberChallenge Trial How Much is Too Much - What is the Role of Cyberknife Radiosurgery in Patients With Multiple Brain Metastases?

ConditionsBrain MetastasesNsclc
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg

About this trial

Patients suffering from malignancies in advanced stages often develop brain metastases, which limit both the life span and the quality of life.

Therapy options for multiple brain metastases may vary and range from stereotactic radiosurgery (SRS), whole-brain radiotherapy (WBRT), chemotherapy, immunotherapy to palliative best supportive care. Especially the efficacy and toxicity of SRS compared to WBRT in patients with extensive brain metastases (\>4) is not yet clear but of incremental relevance in this seriously ill cohort with a limited life span. These health-impaired patients might especially profit from a less toxic treatment that is also time sparing with 1 or few sessions in SRS versus 10 sessions in WBRT. On the other hand, no compromises in efficacy want to be done.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

histologically confirmed malignant illness

4-15 suspect intracranial lesions, taking into consideration all available MRI series

age ≥ 18 years of age

For women with childbearing potential, (and men) adequate contraception.

Disqualifiers

Refusal of the patients to take part in the study

Inability to tolerate irradiation consistent with the protocol

Small-cell lung cancer (SCLC) or lymphoma as primary malignant illness

>15 suspect intracranial lesions, taking into consideration all available MRI series

Trial design

Design model

Parallel

Treatments tested in this trial

  • SRS

    Radiation

    Stereotactic Radiotherapy (SRS)

  • Whole Brain Radiotherapy

    Radiation

    Whole Brain Radiotherapy (WBRT)

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: Experimental Treatment ArmExperimental treatment 1 intervention
Group B: Standard Treatment ArmOther 1 intervention

Trial outcomes

Primary outcomes

1

overall survival

number of alive patients

Time frame
time from randomisation until the date of death from any cause, assesd up to 24 month
2

quality of life according to QLQ-C15 (questionaire for patients with advanced cancer referred for palliative radiotherapy

changes in QLQ-C15 scores, scale is 1-100 points, 100 points representing maximum score

Time frame
time from randomisation until the date of death from any cause, assesd up to 24 month
3

quality of life according to BN-20 (questionaire for patients with brain neoplasm)

changes in BN-20 scores, scale is 1-100 points, 100 points representing maximum score

Time frame
time from randomisation until the date of death from any cause, assesd up to 24 month

Secondary outcomes

1

functional independence assessed by the Barthel ADL index

Changes in Barthel ADL index scores, scale 0-100 points

Time frame
time from randomisation until the date of death from any cause, assesd up to 24 month
2

long-term cognitive Status (Hopkins Verbal Learning Test HVLT)

Changes in HVLT scores (minimum 0, maximum 12)

Time frame
time from randomisation until the date of death from any cause, assesd up to 24 month
3

development of radiation-induced brain lesions

changes in amounts of Radiation-induced brain lesions

Time frame
time from randomisation until the date of death from any cause, assesd up to 24 month
4

Radiation induced sideeffects

changes in toxicity rates according to CTCAE 5.0

Time frame
time from randomisation until the date of death from any cause, assesd up to 24 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Heidelberg

Lead sponsor

Source ClinicalTrials.gov
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