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Stereotactic Radiotherapy of Resection Cavity For Single Brain Metastasis Versus Whole-Brain Radiotherapy After Resection

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ClinicalTrials.gov Identifier: NCT01535209
Recruitment Status : Unknown
Verified February 2012 by Maria Sklodowska-Curie Institute - Oncology Center.
Recruitment status was:  Recruiting
First Posted : February 17, 2012
Last Update Posted : February 17, 2012
Sponsor:
Collaborators:
Lower Silesian Oncology Center
Copernicus Memorial Hospital
Oncology Centre - prof. Franciszek Łukaszczyk Memorial Hospital
Information provided by (Responsible Party):
Maria Sklodowska-Curie Institute - Oncology Center

Study Description
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Brief Summary:
Adjuvant whole-brain radiation therapy (WBRT) after resection of single brain metastasis is considered as a standard associated with side effects leading to decreased neurocognitive function. The Investigators addressed the question whether stereotactic radiotherapy of the resection cavity impairs neurological status and/or cognitive functions in compare to adjuvant WBRT.

Condition or disease Intervention/treatment Phase
Brain Metastases Radiation: stereotactic body radiotherapy (SBRT) Radiation: Whole-Brain Radiotherapy (WBRT) Phase 3

Detailed Description:
Patients with surgically removed single brain metastasis are randomly allocated to control or experimental arm. Before treatment the MRC Neurological Status Scale is used for assessing neurological status, the EORTC QLQ-C30 and QLQ-BN20 for quality of life and Mini-Mental State Examination to assess cognitive functioning. The control group receive 30Gy in 10 fractions of 3Gy over 12 days to the whole brain. The patients in the experimental arm are treated with stereotactic radiotherapy to the resection cavity. The dose to the tumor bed is 15-18Gy in one fraction or 25Gy in 5 fractions. The study hypothesis is that the difference in the 5-months failure free survival rate isn't higher than 25% in experimental arm compared to control arm.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Stereotactic Radiotherapy of the Postoperative Resection Cavity Versus Whole-Brain Irradiation After Surgical Resection of Single Brain Metastasis
Study Start Date : January 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: SBRT to resection cavity
18Gy in 1 fraction for resection cavity <2cm in maximum diameter, 15Gy in 1 fraction for resection cavity 2.1-3cm in maximum diameter, 15Gy in 1 fraction or 25 Gy in 5 fractions over 5 days for resection cavity 3.1-4cm in maximum diameter, 25 Gy in 5 fractions over 5 days for resection cavity >4cm in maximum diameter
 Radiation: stereotactic body radiotherapy (SBRT)
18Gy in 1 fraction for resection cavity <2cm in maximum diameter, 15Gy in 1 fraction for resection cavity 2.1-3cm in maximum diameter, 15Gy in 1 fraction or 25 Gy in 5 fractions over 5 days for resection cavity 3.1-4cm in maximum diameter, 25 Gy in 5 fractions over 5 days for resection cavity >4cm in maximum diameter
Other Name: stereotactic body radiotherapy
Active Comparator: WBRT
30Gy in 10 fractions over 12 days to whole brain
 Radiation: Whole-Brain Radiotherapy (WBRT)
10 x 3 Gy to whole brain
Other Names:
  • whole brain irradiation
  • adjuvant cranial irradiation


Outcome Measures
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Primary Outcome Measures :
  1. Failure-free survival [ Time Frame: 5 months after radiotherapy ]
    Time to decrease in MRC scale by 1 point or in MMSE by 3 points or neurologic death.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
  2. Quality of life assessment [ Time Frame: 2 years ]
  3. Time to distant intracranial progression [ Time Frame: 2 years ]
  4. Time to local progression [ Time Frame: 2 years ]
    Time to progression in the irradiated cavity


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with surgically removed histologically proven metastatic cancer
  • Subtotal or total resection of single brain metastasis
  • Presence of single brain metastasis in MRI
  • Karnofsky Performance Status ≥ 70
  • Life expectancy > 6 months (minimal extracranial disease or availability of effective oncology treatment)
  • No previous history of cranial irradiation
  • Availability of MRI
  • Starting radiotherapy within six weeks after neurosurgery
  • Negative pregnancy test for woman
  • Written informed consent

Exclusion Criteria:

  • Dementia and central nervous system diseases leading to higher risk of radiation toxicity
  • Contraindications for MRI and/or no patient's tolerance and acceptance of cranial MRI
  • Altered level of consciousness
  • Histologically proven metastatic small cell lung cancer
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535209


Contacts
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Contact: Wojciech Michalski, M.S. +48226433909 W.Michalski@coi.waw.pl

Locations
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Poland
M.Sklodowska-Curie Memorial Cancer Centre Recruiting
Warsaw, Poland, 02-781
Contact: Lucyna Kepka, Prof.    +48226439287    lucynak@coi.waw.pl   
Principal Investigator: Lucyna Kepka, Prof.         
Sponsors and Collaborators
Maria Sklodowska-Curie Institute - Oncology Center
Lower Silesian Oncology Center
Copernicus Memorial Hospital
Oncology Centre - prof. Franciszek Łukaszczyk Memorial Hospital
Investigators
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Principal Investigator: Lucyna Kepka, Prof. M.Sklodowska-Curie Memorial Cancer Centre, Warsaw, Poland
More Information
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Responsible Party: Maria Sklodowska-Curie Institute - Oncology Center
ClinicalTrials.gov Identifier: NCT01535209    
Other Study ID Numbers: CAVITY
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012
Keywords provided by Maria Sklodowska-Curie Institute - Oncology Center:
Stereotactic radiotherapy
Whole-brain radiotherapy
Resection cavity
Additional relevant MeSH terms:
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Neoplasm Metastasis
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