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Tumor Bed Hypofractionated IMRT After Surgery for Patients With Single,Large Brain Metastases From Solid Tumor

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ClinicalTrials.gov Identifier: NCT02576522
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas

Brief Summary:
Investigators designed a study of a multimodality approach: surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach for patients with single, large brain metastases from solid primary tumor

Condition or disease Intervention/treatment Phase
Brain Metastases Radiation: brain metastatic patients Not Applicable

Detailed Description:
Investigators designed a study to recruit patients with single, large brain metastases from solid primary tumor for a multimodality approach: surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach. The potential advantage of this treatment is to improve local control and to reduce toxicity compared with WBRT or SRS after surgical resection.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tumor Bed Hypofractionated IMRT (VMAT-RA) After Surgical Resection for Patients With Single, Large (≥2.1 cm) Brain Metastases From Solid Tumor
Actual Study Start Date : June 29, 2015
Actual Primary Completion Date : January 22, 2019
Actual Study Completion Date : January 22, 2019

Arm Intervention/treatment
Experimental: brain metastatic patients
Patients with single, large brain metastases from solid tumors
Radiation: brain metastatic patients
Surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach




Primary Outcome Measures :
  1. Local control rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Distant brain failure [ Time Frame: 6 months ]
  2. Overall survival, statistical [ Time Frame: 6 months ]
  3. Morbidity/mortality after surgery [ Time Frame: 1 month ]
  4. Radionecrosis after treatments [ Time Frame: 6 months ]
  5. Neuropsycological alterations after treatments, questionnaire [ Time Frame: 6 months ]


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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:

  • Age > 18 years
  • Karnosky performance status (KPS) ≥70
  • All Solid tumor (esclusion SCLC and Germinal tumors)
  • Controlled primary tumor
  • Controlled other metastatic site
  • Single metastatic lesion at diagnosis
  • Lesions ≥ 2.1 cm in maximum diameter (4 cm3), < 3 cm conditioning mass effect or neurological deficits or massive aedema, unknown primary tumor
  • Estimated survival ≥ 3 months.
  • Written informed consent

Exclusion Criteria:

  • Prior WBRT
  • KPS ≤ 70
  • Other primary cancer
  • Pregnant women

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): NCT02576522


Locations
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Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Principal Investigator: Pierina Navarria, MD Istituto Clinico Humanitas

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Responsible Party: Michele Tedeschi, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02576522     History of Changes
Other Study ID Numbers: 1408
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019

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