NCT02576522

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2019

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

3.6 years

First QC Date

October 7, 2015

Last Update Submit

May 24, 2019

Conditions

Brain Metastases

Outcome Measures

Primary Outcomes (1)

  • Local control rate

    6 months

Secondary Outcomes (5)

  • Distant brain failure

    6 months

  • Overall survival, statistical

    6 months

  • Morbidity/mortality after surgery

    1 month

  • Radionecrosis after treatments

    6 months

  • Neuropsycological alterations after treatments, questionnaire

    6 months

Study Arms (1)

brain metastatic patients

EXPERIMENTAL

Patients with single, large brain metastases from solid tumors

Radiation: brain metastatic patients

Interventions

brain metastatic patientsRADIATION

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

brain metastatic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Pierina Navarria, MD

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 7, 2015

First Posted

October 15, 2015

Study Start

June 29, 2015

Primary Completion

January 22, 2019

Study Completion

January 22, 2019

Last Updated

May 28, 2019

Record last verified: 2019-05

Locations

IT(1)