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Completed

NCT Number: NCT02576522

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

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

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

brain metastatic patients

Radiation

Surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach

Primary outcomes

  1. Local control rate

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

Tumor Bed Hypofractionated IMRT (VMAT-RA) After Surgical Resection for Patients With Single, Large (≥2.1 cm) Brain Metastases From Solid Tumor

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 15, 2015
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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