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

This study is currently recruiting participants.
Verified October 2015 by Michele Tedeschi, Istituto Clinico Humanitas
Sponsor:
ClinicalTrials.gov Identifier:
NCT02576522
First Posted: October 15, 2015
Last Update Posted: October 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas
  Purpose
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 Intervention Phase
Brain Metastases Radiation: brain metastatic patients Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Michele Tedeschi, Istituto Clinico Humanitas:

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

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

Estimated Enrollment: 55
Study Start Date: June 2015
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Pierina Navarria, MD 00390282247458 marta.scorsetti@cancercenter.humanitas.it

Locations
Italy
Istituto Clinico Humanitas Recruiting
Rozzano, Milano, Italy, 20089
Contact: Pierina Navarria, MD    00390282247458      
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
Principal Investigator: Pierina Navarria, MD Istituto Clinico Humanitas
  More Information

Responsible Party: Michele Tedeschi, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02576522     History of Changes
Other Study ID Numbers: 1408
First Submitted: October 7, 2015
First Posted: October 15, 2015
Last Update Posted: October 15, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Neoplasm Metastasis
Brain Neoplasms
Brain Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases