Accrual to a randomised trial of adjuvant whole brain radiotherapy for treatment of melanoma brain metastases is feasible

BMC Research Notes

John F Thompson³  Elizabeth Paton¹  Lauren E Haydu¹  Bryan Burmeister²  Brindha Shivalingam³  Claudius H Reisse⁴  Kari Dolven Jacobsen⁴  Angela Hong²  Gerald B Fogarty² 

[1] Australia and New Zealand Melanoma Trials Group (ANZMTG), North Sydney, Australia;Trans - Tasman Radiation Oncology Group (TROG), Newcastle, Australia;Sydney Medical School, The University of Sydney, Sydney, Australia;Oslo University Hospital HF, The Norwegian Radium Hospital, Oslo, Norway

关键词: Randomised trial;    Whole brain radiotherapy;    Feasibility;    Pilot project;    Trial;    Brain;    Melanoma;    Metastases;    Radiotherapy;   

Others  :  826381
DOI  :  10.1186/1756-0500-7-412

 received in 2014-01-31, accepted in 2014-06-20,  发布年份 2014

【 摘 要 】

Background

Brain metastases (BMs) are common in melanoma patients. Adjuvant whole brain radiotherapy (WBRT) following local treatment of intracranial melanoma metastases with neurosurgery and/or stereotactic radiosurgery is controversial. A randomised trial is needed. However, accrual to WBRT trials has been problematic. A pilot study by Australia and New Zealand Melanoma Trials Group (ANZMTG) was conducted to see if accrual was feasible.

Methods

Sites canvassed for interest included those who treat melanoma patients, had a proven accrual in previous melanoma trials and who had the relevant infrastructure support. Feasibility forecasts from interested sites were sought. These were compared to the patient numbers documented in the research contracts. A target accrual of 60 patients in 2 years was set. Funding was sought for the pilot study. Basic demographics of the pilot study cohort were collected.

Results

The first centre opened December 2008; the first patient was randomised in April 2009. The pilot accruing period concluded in September, 2011. In 30 months, 54 patients from 10 of a total of 17 activated sites in Australia (39, 72%) and in Norway (15, 28%) had been accrued. Feasibility forecasts predicted 133 trial eligible patients per year (including 108 Australian + 25 International patients). Site estimates generally overestimated accrual with 4 of 17 active sites estimating within 50% of target numbers. Sites with patient estimates calculated from records were more accurate than those estimated from memory. The overall recruitment target was lower in the research contracts when compared to the feasibility evaluation. Basic demographics of the pilot study revealed 62% of patients were males; 58% had a single metastasis, 28% had two and 14% had three metastases. 12-month overall survival was 50%.

Conclusions

Despite only 54 patients and not the full 60 patient target being accrued in two years the Trial Management Committee and Data Safely Monitoring Committee approved the continuation of the pilot study to the main trial. On the basis of this successful pilot study, funding was achieved for the full study. 143 patients of a target of 200 have been randomised by June 2014.

【 授权许可】

   
2014 Fogarty et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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