Volumetric Modulated Arc Therapy (VMAT) for Brain Metastases

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alan Nichol, British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT01046123
First received: January 7, 2010
Last updated: February 4, 2014
Last verified: February 2014

January 7, 2010
February 4, 2014
January 2010
December 2019   (final data collection date for primary outcome measure)
3 month treatment response of metastases evaluated using contrast-enhanced MRI scan of brain [ Time Frame: 3 months post treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01046123 on ClinicalTrials.gov Archive Site
  • 1-year local control of treated metastases evaluated with contrast-enhanced MRI scan of brain [ Time Frame: 1 year post-treatment ] [ Designated as safety issue: No ]
  • 1-year brain control of metastases evaluated with contrast-enhanced MRI scan of brain [ Time Frame: 1 year post-treatment ] [ Designated as safety issue: No ]
  • Median survival [ Time Frame: No time frame ] [ Designated as safety issue: No ]
  • Both acute neurological toxicity (within 3 months of treatment) and late neurological toxicity (beyond 3 months of treatment [ Time Frame: 3 months and beyond ] [ Designated as safety issue: No ]
  • Time to decline in activities of daily living evaluated using the Modified Barthel index [ Time Frame: No time frame ] [ Designated as safety issue: No ]
  • Time to decline in cognition evaluated with the Mini-mental state examination [ Time Frame: No time frame ] [ Designated as safety issue: No ]
  • 1-year local control of treated metastases evaluated with contrast-enhanced MRI scan of brain [ Time Frame: 1 year post-treatment ] [ Designated as safety issue: No ]
  • 1-year brain control of metastases evaluated with contrast-enhanced MRI scan of brain [ Time Frame: 1 year post-treatment ] [ Designated as safety issue: No ]
  • Median survival [ Designated as safety issue: No ]
  • Both acute neurological toxicity (within 3 months of treatment) and late neurological toxicity (beyond 3 months of treatment [ Designated as safety issue: No ]
  • Time to decline in activities of daily living evaluated using the Modified Barthel index [ Designated as safety issue: No ]
  • Time to decline in cognition evaluated with the Mini-mental state examination [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Volumetric Modulated Arc Therapy (VMAT) for Brain Metastases
A Phase II Study of Whole Brain Radiotherapy With Simultaneous Integrated Boost Using Volumetric Modulated Arc Therapy for One to Ten Brain Metastases

Radiotherapy to the whole brain is standard treatment for cancer that has spread to the brain (brain metastases) as it treats both the metastases that can be seen on scans and the brain metastases that are too small to be seen on scans.

This study will use a novel radiotherapy technique, called volumetric modulated arc therapy (VMAT), to treat patients with brain metastases. This technique allows delivery of both a standard radiation dose to the whole brain as well as a higher radiation dose to the brain metastases at the same time.

The study will assess the effectiveness of using VMAT in treating brain metastases, and examine its potential side-effects.

This is a Phase II prospective clinical trial. Following registration, patients will be required to undertake a baseline questionnaire assessment of daily living activities using the Modified Barthel's index, as well as cognitive assessment using MMSE.

Patients will undergo MRI scan of the brain for radiotherapy planning purposes. During radiotherapy planning and for each of the five radiotherapy fractions, patients will be immobilised in a custom fitted stereotactic mask system, to minimise head movement. During treatment, patients will have daily online setup corrections to ensure treatment accuracy.

Patients will be treated with WBRT/SIB using VMAT, delivering a total of 20 Gy in 5 fractions to the whole brain and 50Gy in 5 fractions to the brain metastases, delivered once daily on working days. Anti-nausea and anti-inflammatory medication will be prescribed to minimise acute toxicity.

Following therapy completion, patients will be seen every 3 months for the 1st year, then every 6 months thereafter. At each clinic visit, clinicians or study investigators will monitor for toxicity from therapy, document neurologic symptoms and signs and performance status as well as Modified Barthel's index and cognitive assessment.

Patients will have contrast-enhanced MRI brain at 3 months and 1 year, and contrast-enhanced CT brain at 6 months and 9 months in the first year and every 6 months after the first year. Serum creatinine levels will be done prior to each scan to ensure safety of intravenous contrast administration.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Brain Metastases
Radiation: whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy
Patients will be treated with WBRT/SIB using VMAT, delivering a total of 20 Gy in 5 fractions to the whole brain and 50Gy in 5 fractions to the brain metastases, delivered once daily on working days.
Experimental: Whole brain radiotherapy
whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy
Intervention: Radiation: whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2019
December 2019   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 18
  • pathologically confirmed solid malignancy diagnosed within the past 5 years (if the original pathological cancer diagnosis is more than 5 years earlier, a biopsy to confirm metastatic relapse within the past 5 years is required)
  • 1-10 brain metastases
  • Maximum diameter of largest metastasis ≤ 3 cm
  • KPS ≥ 70
  • Patient is neurologically stable with or without corticosteroids
  • Extracranial disease well-controlled (6-month estimated median life expectancy).
  • Available for regular clinical and imaging follow up
  • Prior craniotomy permitted

Exclusion Criteria:

  • Require craniotomy to relieve mass effect
  • Previous cranial radiotherapy
  • Metastatic germinoma, small cell carcinoma, multiple myeloma, lymphoma or leukaemia.
  • Chemotherapy administered within one week before radiotherapy or planned within one week after radiotherapy.
  • Metastases within 0.7 cm of the optic chiasm, brainstem or optic nerves
  • Brainstem metastases
  • Systemic lupus erythematosis, scleroderma, or other connective tissue disorders not in remission
  • Multiple sclerosis
  • Glomerular Filtration Rate < 60 ml/minute
  • Non-small cell lung cancer with liver metastases
  • Bilirubin > upper normal limit
  • AST or ALT > 2X upper normal limit
  • Pregnancy
  • Summed volume of all metastasis PTVs > 50 cm3
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01046123
WHAM!
Yes
Alan Nichol, British Columbia Cancer Agency
British Columbia Cancer Agency
Not Provided
Principal Investigator: Alan Nichol, MD British Columbia Cancer Agency
British Columbia Cancer Agency
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP