NCT00328575

Brief Summary

The purpose of this study is to determine if using intensity modulated radiation therapy for brain metastases is safe and will improve local control more than standard whole brain radiation therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_1

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

October 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

3.8 years

First QC Date

May 19, 2006

Last Update Submit

October 19, 2016

Conditions

Neoplasm Metastasis

Keywords

Brain metastasesParenchymalNeoplasmIMRTIntensity Modulated Radiation Therapy

Outcome Measures

Primary Outcomes (1)

  • Unacceptable Acute CNS Toxicity

    The primary endpoint is the frequency of patients developing unacceptable acute CNS toxicity.

    3 weeks

Secondary Outcomes (1)

  • Dose-Limiting Toxicity (DLT)

    30 days

Study Arms (1)

Intensity-Modulated Radiotherapy (IMRT)

EXPERIMENTAL

Patients with brain metastases will be enrolled in one of three dose levels based on tumor size. For tumor size of 3 cm or less (maximum diameter in any dimension), doses of 47.5Gy, 52.5Gy, and 54.5Gy will be tested. For tumor size of greater than 3 cm (maximum diameter in any dimension), doses of 42.5Gy, 47.5Gy, and 52.5Gy will be tested.

Radiation: Intensity-Modulated Radiotherapy (IMRT)

Interventions

Intensity-Modulated Radiotherapy (IMRT)RADIATION

The duration of radiation therapy will be total of 3 weeks. During the first week, all patients will be treated initially with whole brain radiation therapy (WBRT) at 2.5Gy per fraction daily 5 days a week to a dose of 12.5Gy. This will be delivered through parallel-opposed fields to cover the entire cranial contents. For the remaining 2 weeks, patients will be treated using intensity-modulated radiation therapy (IMRT) technology such that a higher dose can be delivered to the tumor. IMRT is capable of generating complex 3-D dose distribution to conform closely to the target volume by modulating the radiation beam. This process is based on the "inverse method" of treatment planning to optimize radiation dose to tumor target coverage and normal tissue sparing.

Also known as: Radiation Therapy
Intensity-Modulated Radiotherapy (IMRT)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed malignancy
  • parenchymal brain metastases on magnetic resonance imaging (MRI) with a maximum size of 4 cm
  • Partial resection allowed. Complete resection allowed only in patients with more than 3 lesions.
  • Karnofsky Performance Status (KPS) equal to or greater than 60
  • Neurologic function equal to or greater than 2

You may not qualify if:

  • Recurrent brain tumors
  • Major medical or psychiatric illnesses
  • Metastases in brainstem, midbrain, pons, or medulla
  • Patients with leukemia or lymphoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasm MetastasisBrain NeoplasmsNeoplasms

Interventions

Radiotherapy, Intensity-ModulatedRadiotherapy

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedTherapeutics

Study Officials

  • Wenyin Shi, MD, PhD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2006

First Posted

May 22, 2006

Study Start

October 1, 2005

Primary Completion

July 1, 2009

Study Completion

June 1, 2011

Last Updated

October 21, 2016

Record last verified: 2016-10

Locations

US(1)