Overview

This trial is active, not recruiting.

Condition brain metastases
Treatment whole brain radiotherapy (wbrt) and a simultaneous integrated boost (sib) using volumetric modulated arc therapy
Phase phase 2
Sponsor British Columbia Cancer Agency
Start date January 2010
End date June 2013
Trial size 60 participants
Trial identifier NCT01046123, WHAM!

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy
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.

Primary Outcomes

Measure
3 month treatment response of metastases evaluated using contrast-enhanced MRI scan of brain
time frame: 3 months post treatment

Secondary Outcomes

Measure
1-year local control of treated metastases evaluated with contrast-enhanced MRI scan of brain
time frame: 1 year post-treatment
1-year brain control of metastases evaluated with contrast-enhanced MRI scan of brain
time frame: 1 year post-treatment
Median survival
time frame: No time frame
Both acute neurological toxicity (within 3 months of treatment) and late neurological toxicity (beyond 3 months of treatment
time frame: 3 months and beyond
Time to decline in activities of daily living evaluated using the Modified Barthel index
time frame: No time frame
Time to decline in cognition evaluated with the Mini-mental state examination
time frame: No time frame

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Alan Nichol, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by British Columbia Cancer Agency.