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A Phase II Multi-institutional Study Assessing Simultaneous In-Field Boost Helical Tomotherapy for 1-3 Brain Metastases


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastasis to Brain of Primary Cancer

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Trial Information

A Phase II Multi-institutional Study Assessing Simultaneous In-Field Boost Helical Tomotherapy for 1-3 Brain Metastases


Inclusion Criteria:



- Histological diagnosis of primary cancer

- Contrast enhanced MRI demonstrating 1-3 metastases within 6 weeks of enrollment

- Age greater than or equal to 18

- Karnofsky performance status greater than or equal to 70

- Patient available for subsequent follow-up appointments and testing as well as
health-related quality of life questionnaires

- Anticipated survival (independent of the brain metastases) greater than 3 months

- Patient informed consent obtained

- Metastatic suitable for synchronous boost

- Extracranial disease controlled or to be treated

Exclusion Criteria:

- Underlying medical condition precluding adequate follow-up

- Prior cranial radiotherapy

- Concurrent cytotoxic chemotherapy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

At approximately end of year 4 (study completion)

Safety Issue:

No

Principal Investigator

George Rodrigues, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

London Regional Cancer Program of the Lawson Health Research Institute

Authority:

Canada: Ethics Review Committee

Study ID:

R-10-204

NCT ID:

NCT01543542

Start Date:

April 2010

Completion Date:

April 2014

Related Keywords:

  • Metastasis to Brain of Primary Cancer
  • 1-3 brain metastases from any primary cancer
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms

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