Trial document




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  DRKS00005127

Trial Description

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Title

Whole brain helical tomotherapy with integrated boost for brain metastases in patients with malignant melanoma – a randomized trial

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Trial Acronym

BRAIN-RT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Comparison of a conventional whole-brain radiotherapy in patients with brain metastases from malignant melanoma with a special radiation therapy technique (helical Tomotherapy) with dose escalation to the single brain metastases.

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Brief Summary in Scientific Language

Patients with malignant melanoma (MM) may develop cerebral metastases, requiring radiotherapeutic treatment. In patients with 1-3 intracerebral lesions, stereotactic radiosurgery (SRS) has been established as a treatment option. For patients with 4 or more lesions, whole brain radiotherapy (WBRT) is considered the standard treatment. In certain patients with cerebral metastases, radiation treatment using whole brain helical tomotherapy with integrated boost and hippocampal-sparing may be indicated.
The present trial aims to exploratory investigate the treatment response to ‘conventional whole brain radiotherapy ’and ‘whole brain helical tomotherapy with integrated boost and hippocampal-sparing’ in melanoma patients.
The primarily investigated endpoint is treatment toxicity. Secondary endpoints include imaging response, local and loco-regional progression-free survival, overall survival and quality of life.

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Organizational Data

  •   DRKS00005127
  •   2013/07/03
  •   [---]*
  •   yes
  •   Approved
  •   S-327/2012, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   C79.3 -  Secondary malignant neoplasm of brain and cerebral meninges
  •   C43 -  Malignant melanoma of skin
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Interventions/Observational Groups

  •   helical Tomotherapy of the whole brain (10x3Gy) with integrated boost to the brain metastases (10x5Gy) and hippocampal-sparing
  •   conventional whole-brain radiotherapy 10x3Gy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Toxicity quantified by absolute frequencies and percentages of side effects according to CTC Criteria Version 4. Follow-up visits every ~2 months for in total 1 year

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Secondary Outcome

imaging response, local and loco-regional progression-free survival, overall survival and quality of life
Imaging response will be evaluated according to the RECIST criteria and represented by percentages. Kaplan-Meier curves will be plotted and Cox-regression analyses will be conducted to investigate possible factors influencing survival. QoL will be measured with the EORTC-QoL-Q C30 and brain module BN-20, and results will be summarized by median, minimum and maximum scores, and represented by box plots. Follow-up visits (as previously mentioned in section primary endpoint) every ~2 months for 1 year

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/08/16
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• histologically confirmed malignant melanoma (MM)
• MR-imaging confirmed >1 cerebral metastases (in case of resection, >1 remaining metastases)
• age ≥ 18 years of age
• Karnofsky Performance Score >/=60
• For women with childbearing potential, (and men) adequate contraception.
• Ability of subject to understand character and individual consequences of the clinical trial
• Written informed consent (must be available before enrolment in the trial)

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Exclusion Criteria

• refusal of the patients to take part in the study
• previous radiotherapy of the brain
• Patients who have not yet recovered from acute high-grade toxicities of prior therapies
• Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
• Pregnant or lactating women
• Participation in another clinical study or observation period of competing trials, respectively
• MRI contraindication (i.e. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants)

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Abteilung für Strahlentherapie
    • Mr.  PD Dr.  Florian  Sterzing 
    • INF 400
    • 69120  Heidelberg
    • Germany
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    • Abteilung für Strahlentherapie
    • Studiensekretariat  der Strahlentherapie 
    • INF 400
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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