Flame trial

This effect is proposed to be due to a non-vascular mechanism, possibly related to a serotonin-mediated suppression of post-stroke hyperexcitability in the unaffected hemisphere leading to improved neuroplasticity. The medication was well-tolerated. While the FLAME trial is generally regarded as a well-designed, well-executed and sufficiently powered trial, its restrictive inclusion criteria, small sample size, and short follow-up limit the generalization of its findings in clinical practice.

Presented as fluoxetine vs. All outcomes are at day Change in FMMS from baseline. Methods: In this double-blind, placebo-controlled trial, patients from nine stroke centres in France who had ischaemic stroke and hemiplegia or hemiparesis, had Fugl-Meyer motor scale FMMS scores of 55 or less, and were aged between 18 years and 85 years were eligible for inclusion.

Patients were randomly assigned, using a computer random-number generator, in a ratio to fluoxetine 20 mg once per day, orally or placebo for 3 months starting days after the onset of stroke.

All patients had physiotherapy. The primary outcome measure was the change on the FMMS between day 0 and day 90 after the start of the study drug.

Participants, carers, and physicians assessing the outcome were masked to group assignment. Intermediate and high risk prostate cancer, defined by Ash et al.

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Rationale: Dose escalation in external-beam irradiation has proven to benefit outcome in local prostate cancer. Randomized trials were performed up to doses of 78 Gy in 2 Gy fractions. Therefore further dose escalation seems to be required. A feasibility study up to appr. Higher doses to the entire prostate are expected to increase severe toxicity. As local recurrences only occur at the site of the primary macroscopic tumour area the next step in increasing the dose should be an ablative boost to the macroscopic tumour alone, while electively irradiating the rest of the prostate to the current gold standard dose.

Feasibility of this approach has been shown for an ablative dose of 95 Gy to the macroscopic tumour within the prostate. Detailed Description:. Objective: Primary study objective: To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care. Secondary study objectives: Establish and compare the rates of treatment-related toxicity, quality of life and disease-free survival.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will have to fill in a quality of life questionnaire before and after the radiotherapy treatments.

MedlinePlus related topics: Prostate Cancer. FDA Resources. Arms and Interventions.