FRAGMATIC - A Randomised Phase III Clinical Trial Investigating the Effect of FRAGMin Added to Standard Therapy In Patients With Lung Cancer
- Determine whether the addition of dalteparin results in improved survival.
- Determine venous thrombotic event-free survival and metastasis-free survival.
- Determine serious adverse events in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Determine the quality of life, breathlessness, anxiety, and depression in patients
treated with this drug.
- Determine the cost effectiveness and cost utility of this drug.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (control): Patients receive anticancer treatment considered appropriate by the
local medical team.
- Arm II: Patients receive anticancer treatment considered appropriate by the local
medical team. Beginning before the start of the first definitive anticancer treatment,
patients receive dalteparin subcutaneously daily for up to 24 weeks.
Quality of life, anxiety, depression, and dyspnea are assessed at baseline, at 12 and 24
weeks, and then at 9 and 12 months.
After completion of therapy, patients are followed at 9 months, 1 year, and then every 6
months for at least 2 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Fergus Macbeth, MD
Velindre NHS Trust