Volumetric Modulated Arc Therapy (VMAT) for Brain Metastases

NCT01046123 | Unknown DMC

• 1 other identifier: WHAM!
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Metastases

Outcome Measures

Primary Outcomes (1)

• 3 month treatment response of metastases evaluated using contrast-enhanced MRI scan of brain

  3 months post treatment

Secondary Outcomes (6)

• 1-year local control of treated metastases evaluated with contrast-enhanced MRI scan of brain

  1 year post-treatment

• 1-year brain control of metastases evaluated with contrast-enhanced MRI scan of brain

  1 year post-treatment

• Median survival

  No time frame

• Both acute neurological toxicity (within 3 months of treatment) and late neurological toxicity (beyond 3 months of treatment

  3 months and beyond

• Time to decline in activities of daily living evaluated using the Modified Barthel index

  No time frame

Study Arms (1)

Whole brain radiotherapy

EXPERIMENTAL

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

Interventions

whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy RADIATION

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.

Whole brain radiotherapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Related Publications (2)

• Chan M, Ferguson D, Ni Mhurchu E, Yuan R, Gondara L, McKenzie M, Olson R, Thiessen B, Lalani N, Ma R, Nichol A. Patients with pretreatment leukoencephalopathy and older patients have more cognitive decline after whole brain radiotherapy. Radiat Oncol. 2020 Nov 25;15(1):271. doi: 10.1186/s13014-020-01717-x.

  PMID: 33239056 DERIVED

• Nichol A, Ma R, Hsu F, Gondara L, Carolan H, Olson R, Schellenberg D, Germain F, Cheung A, Peacock M, Bergman A, Vollans E, Vellani R, McKenzie M. Volumetric Radiosurgery for 1 to 10 Brain Metastases: A Multicenter, Single-Arm, Phase 2 Study. Int J Radiat Oncol Biol Phys. 2016 Feb 1;94(2):312-21. doi: 10.1016/j.ijrobp.2015.10.017. Epub 2015 Oct 22.

  PMID: 26678660 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Alan M Nichol, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 11, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

CA (1)