Whole Brain Radiotherapy Versus Volumetric Modulated Arc Therapy for Brain Metastases

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02220491
• Date of registration: 15/08/2014
• Prospective Registration: Yes
• Primary sponsor: British Columbia Cancer Agency
• Public title: Whole Brain Radiotherapy Versus Volumetric Modulated Arc Therapy for Brain Metastases Amadeus
• Scientific title: A Randomized Phase II Study of 20 Gy in 5 Fractions Whole Brain Radiotherapy Versus 15 Gy in 1 Fraction Volumetric Modulated Arc Therapy for One to Ten Brain Metastases
• Date of first enrolment: October 1, 2014
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02220491
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Nichol Alan, MD
• Affiliation: British Columbia Cancer Agency

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age = 18

- Pathologically confirmed solid malignancy

- 1-10 brain or brainstem metastases on MRI with a maximum of 4 cm diameter

- Documented extracranial disease

- Anticipated median survival 3-6 months (Graded Prognostic Assessment: Appendix I)

- Available for regular clinical and imaging follow up (< 1 hour from a cancer centre)

- Montreal Cognitive Assessment score = 20 (Appendix II)

- Karnofsky Performance Score (KPS) = 70 (Appendix III)

- Barthel Activities of Daily Living score = 90 (Appendix IV)

- Able to complete EORTC quality of life questionnaires (Appendix V)

Exclusion Criteria:

- A metastasis located within 5 mm of the optic nerves or optic chiasm

- Requiring craniotomy to relieve mass effect

- Cytotoxic systemic therapy administered within one week before radiotherapy or planned
within one week after radiotherapy

- Neurological decline since starting corticosteroids

- Metastatic germinoma, small cell carcinoma, multiple myeloma, lymphoma or leukaemia

- Systemic lupus erythematosis, scleroderma, or other connective tissue disorders not in
remission

- Multiple sclerosis

- Glomerular Filtration Rate < 45 ml/minute

- Contra-indications to MRI

- Pregnancy

- AST, ALT or Bilirubin > 3 times upper limit of normal

- Haemorrhagic Metastases



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Brain Metastases

Intervention(s)

Radiation: Whole-brain radiotherapy

Radiation: Single-fraction radiotherapy

Primary Outcome(s)

Accrual [Time Frame: 8 months]

Secondary Outcome(s)

Intracranial disease control [Time Frame: 3 months]

Secondary ID(s)

H14-02032

Source(s) of Monetary Support

Please refer to primary and secondary sponsors