Volumetric Modulated Arc Therapy (VMAT) for Brain Metastases - Full Text View

Sponsor:	British Columbia Cancer Agency
Information provided by (Responsible Party):	Alan Nichol, British Columbia Cancer Agency
ClinicalTrials.gov Identifier:	NCT01046123

Purpose

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.

Condition	Intervention	Phase
Brain Metastases	Radiation: whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy	Phase 2

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Whole Brain Radiotherapy With Simultaneous Integrated Boost Using Volumetric Modulated Arc Therapy for One to Ten Brain Metastases

Resource links provided by NLM:

MedlinePlus related topics: Cancer MRI Scans Nuclear Scans

U.S. FDA Resources

Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	60
Study Start Date:	January 2010
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Whole brain radiotherapy whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy	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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046123

Contacts

Contact: Alan Nichol, MD

604-877-6000 ext 2380

anichol@bccancer.bc.ca

Locations

Canada, British Columbia
BC Cancer Agency - Vancouver Centre	Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6

Sponsors and Collaborators

British Columbia Cancer Agency

More Information

No publications provided

Responsible Party:	Alan Nichol, Radiation Oncologist, British Columbia Cancer Agency
ClinicalTrials.gov Identifier:	NCT01046123 History of Changes
Other Study ID Numbers:	WHAM!
Study First Received:	January 7, 2010
Last Updated:	February 1, 2012
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes

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

ClinicalTrials.gov processed this record on May 23, 2012