A Randomised Trial Investigating the Additional Benefit of Hydroxychloroquine(HCQ)to Short Course Radiotherapy (SCRT) in Patients Aged 70 Years and Older With High Grade Gliomas (HGG)
There is emerging evidence that hydroxychloroquine (HCQ), a drug used commonly in the prevention/ treatment of malaria, rheumatoid arthritis and lupus erythematosus, may improve survival outcome in a variety of cancers including HGG, with few side effects.
In this trial the investigators wish to investigate whether treatment with radiotherapy and hydroxychloroquine is more effective than treatment with radiotherapy alone.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomised Phase 2 Trial Investigating the Additional Benefit of Hydroxychloroquine(HCQ)to Short Course Radiotherapy (SCRT) in Patients Aged 70 Years and Older With High Grade Gliomas (HGG)|
- 1 year Survival [ Time Frame: The survival rate will be calculated by the number of patients alive 1 year after entering the trial. ] [ Designated as safety issue: No ]The primary endpoint of the trial is survival at one year
- Toxicity [ Time Frame: Toxicity will be assessed during and up to 30 days after treatment ] [ Designated as safety issue: Yes ]Adverse Events will be collected for all patients in the trial during treatment and up to 30 days afterwards.
|Study Start Date:||May 2013|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm B
Patients randomised to Arm B will receive Short Course Radiotherapy plus Hydroxychloroquine 200mg bd from 14 days post surgery until clinical or radiological progression.
200mg bd from 14 days post surgery until clinical or radiological progression
Other Name: HCQ
Active Comparator: Arm A: SCRT alone
Patients randomised to Arm A will receive standard treatment of Short Course Radiotherapy
Short Course radiotherapy
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602588
|Contact: Ka Man Condne||0207 679 firstname.lastname@example.org|
|St James's University Hospital||Recruiting|
|Leeds, West Yorkshire, United Kingdom, LS9 7TF|
|Principal Investigator: Susan Short, Professor|