CASPS

• Research type

  Research Study

• Full title

  A Phase II Trial of Cediranib in the Treatment of Patients with Alveolar Soft Part Sarcoma (CASPS).

• IRAS ID

  60384

• Contact name

  Ian Judson

• Sponsor organisation

  The Institute of Cancer Research

• Eudract number

  2010-021163-33

• ISRCTN Number

  N/A

• Research summary

  Alveolar soft part sarcoma (ASPS) is a cancer found in soft tissue, usually in the limbs, head and neck of young adults. ASPS is very rare, with an estimated incidence of 15 cases per year in the UK. The disease spreads to other parts of the body (metastasises) at a high rate, but often then becomes dormant meaning patients can survive for more than 3 years with metastatic (advanced) disease.Standard chemotherapy shows no benefit in ASPS patients and there is no alternative standard accepted treatment.Cediranib is the drug under investigation. It works by blocking the action of a growth factor called Vascular Endothelial Growth Factor (VEGF). VEGF encourages the formation of new blood vessels in the body. As tumours need a blood supply in order to grow, stopping VEGF from working may slow tumour growth and therefore disease progression in ASPS. The CASPS study aims to investigate the role of cediranib in patients with metastatic ASPS. The primary objective of the trial is to compare the size of patients tumours after 24 weeks of cediranib treatment, compared to treatment with a placebo. Treatment allocation will be randomly assigned and neither doctor or patient will know which treatment is being received. Two patients will receive cediranib, for every one patient receiving placebo.At 24 weeks, patients taking placebo can start cediranib treatment and patients already receiving cediranib can continue treatment. All patients continue to take cediranib until their clinician judges they are no longer benefitting ie. their disease gets worse (progression). Patients will undergo routine safety assessments and have regular scans to assess how their disease is responding.Male or female patients, age 16 and over with ASPS which has progressed in the last 6 months are eligible. The trial will be conducted in NHS centres across the UK, and internationally.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  10/H0806/118

• Date of REC Opinion

  18 Feb 2011

• REC opinion

  Further Information Favourable Opinion