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| Sponsor: | University Hospital, Essen |
|---|---|
| Information provided by: | University Hospital, Essen |
| ClinicalTrials.gov Identifier: | NCT00876759 |
Purpose
Brain metastases occur in 20-40% of patients with primary extracerebral tumors. Despite important advances in therapy of malignant solid tumors and treatment of 1-3 brain metastases, multiple brain metastases continue to present a significant problem in attempting to prevent progression of disease and limit morbidity associated with therapy. The majority of patients who develop brain metastases have a short survival, effective palliation being transient. The median survival after diagnosis is as low as 3-6 months. However, there is some evidence that selected patients survive prolonged periods with vigorous therapeutic approach.
Specific therapeutic options are surgery, chemotherapy, conventional fractionated whole-brain radiotherapy (WBRT) and radiosurgery. Radiosurgery allows delivering of a single high dose fraction of radiation to targets of 3-3.5 cm maximum diameter. In patients with newly diagnosed brain metastases, a rapid decrease of symptoms, local tumor response rate of 73-90% and a median survival of 7-12 month have been reported.
WBRT alone is the treatment of choice for patients with multiple brain metastases, and for patients with single brain metastases not amenable to surgery or radiosurgery. Median survival after WBRT alone is 3-6 months.
WBRT and radiosurgery boost have been shown to improve survival in RPA class I patients and in patients with favorable histological status and squamous cell or non-small cell lung tumors. All randomized trials showed improved local control with the addition of radiosurgery to WBRT (Andrews, 2004).
WBRT in conjunction with radiosurgery improves local control and reduces the risk of new distant brain metastases, but most studies support that combined radiosurgery and WBRT does not improve the overall survival expect for patients without evidence of extracranial disease.
Helical Tomotherapy (HT) allows as a sole modality a new treatment option: Using HT, the advantage of applying a highly conformal boost dose to the metastases and WBRT can be combined in one treatment session. Therefore, it allows applying a high dose to multiple brain metastases in the sense of an integrated boost. The focus of this study is to investigate the efficacy and safety of WBRT with an integrated boost using this new treatment modality in comparison to the effects of conventional WBRT alone.
The principal objective of the trial is to assess the therapeutic efficacy of WBRT as compared to WBRT combined with integrated boost with HT delivered to patients with 2-10 brain metastases of solid tumors. The secondary objective is to evaluate the safety of WBRT as opposed to WBRT combined with integrated boost as delivered by HT in patients with 2-10 brain metastases.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Metastases |
Radiation: whole brain radiotherapy Radiation: whole brain radiotherapy with simultaneous boost |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Whole-Brain Radiotherapy (WBRT) vs. WBRT and Integrated Boost Using Helical Tomotherapy for Patients With Multiple Brain Metastases - a Multicentre Randomized Phase II Trial |
| Estimated Enrollment: | 160 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: WBRT
standard WBRT to a total dose of 30 Gy in 10 fractions
|
Radiation: whole brain radiotherapy
WBRT in 10 fractions to a total dose of 30Gy
|
|
Experimental: WBRT with simulatneous boost
The experimental group will be treated with helical tomotherapy giving 3 Gy per fraction to the whole brain up to a total dose of 30 Gy in 10 fractions and raising the prescribed dose to the brain metastases to 5 Gy per fraction. The dose fall off to the normal brain should be as steep as possible around each brain metastasis. The optic chiasm and the optic nerves should not receive more than 3.5 Gy per fraction.
|
Radiation: whole brain radiotherapy with simultaneous boost
Total dose: 10 fractions: whole brain total dose: 30Gy, metastases: total dose 50Gy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Andrea Wittig, MD | +49201723 ext 2050 | andrea.wittig@uni-due.de |
| Contact: Martin Stuschke, MD pHD | +49201723 ext 2321 | martin.stuschke@uni-due.de |
| Germany | |
| University Duisburg-Essen, Medical Faculty, department of Radiation Oncology | Recruiting |
| Essen, NRW, Germany, 45122 | |
| Contact: Andrea Wittig, MD +49201723 ext 2050 andrea.wittig@uni-due.de | |
| Contact: Martin stuschke, MDpHD +49201723 ext 2321 martin.stuschke@uni-due.de | |
| Principal Investigator: Martin Stuschke, MD pHD | |
| Klinik für Strahlentherapie Charite Campus Mitte | Not yet recruiting |
| Berlin, Germany, 10117 | |
| Contact: Volker Budach, MD pHD +49-30-450527 ext 021 volker.budach@charite.de | |
| Contact: Simone Marnitz, MD pHD 49-30-450527 ext 162 Simone.Marnitz@charite.de | |
| Principal Investigator: Volker Budach, MD pHD | |
| Universitätsklinikum Hamburg Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Strahlentherapie, | Not yet recruiting |
| Hamburg, Germany, 20246 | |
| Contact: Rudolf Schwarz, MD pHD 040 42803 ext 5425 rschwarz@uke.uni-hamburg.de | |
| Principal Investigator: Rudolf Schwarz, MDpHD | |
| Jürgen Debus | Not yet recruiting |
| Heidelberg, Germany, 69120 | |
| Contact: Jürgen Debus, MD pHD +49-6221 ext 56 8202 juergen.debus@med.uni-heidelberg.de | |
| Contact: Klaus Herfarth, MDpHD +49-6221 ext 56 8202 klaus.herfarth@med.uni-heidelberg.de | |
| Principal Investigator: Klaus Herfarth, MD pHD | |
| Klinik und Poliklinik für Strahlentherapie und Radiologische Onkologie, Klinikum rechts der Isar, Technische Universität München | Not yet recruiting |
| München, Germany, 81675 | |
| Contact: Michael Molls, MD pHD + 49 89 4140 ext 4501 Molls@lrz.tu-muenchen.de | |
| Contact: Hans Geinitz, MD pHD 089/4140 ext 4525 hans.geinitz@lrz.tu-muenchen.de | |
| Principal Investigator: Hans Geinitz, Md pHD | |
| Principal Investigator: | Martin Stuschke, MD pHD | University Duisburg-Essen, Medical Faculty, Department of Radiation Oncology |
More Information
| Responsible Party: | Prof. Dr. med. Martin Stuschke, Department of Radiation Oncology, Medical Faculty, University Duisburg-essen |
| ClinicalTrials.gov Identifier: | NCT00876759 History of Changes |
| Other Study ID Numbers: | Tomo0701 |
| Study First Received: | April 6, 2009 |
| Last Updated: | April 6, 2009 |
| Health Authority: | Germany: Ethics Commission |
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cerebral metastases |
|
Neoplasm Metastasis Neoplasms, Second Primary Brain Neoplasms Neoplastic Processes Neoplasms Pathologic Processes |
Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |