AAA-III-01

• Research type

  Research Study

• Full title

  A multi-centre, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumours.

• IRAS ID

  97459

• Contact name

  Ashley Grossman

• Sponsor organisation

  Advanced Accelerator Applications

• Eudract number

  2011-005049-11

• Duration of Study in the UK

  7 years, 7 months, 0 days

• Research summary

  Does tumour-targeted peptide receptor radionucleotide therapy (PRRT) prevent worsening of the disease in patients with inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumours?

  Therapy with Octreotide LAR administered intramuscularly is nowadays considered as standard treatment of the progressive, somatostatin-positive, midgut carcinoid tumours. An alternative therapy, the so-called PRRT, based on a treatment with radioactive product (177Lu-DOTA0-Tyr3-Octreotate) is presently under development by Advanced Accelerator Applications, France. The radioactive product is a somatostatin-peptide analogue attached to a radioactive drug which delivers strong radiation directly into the tumour and thus causes death of the cancer-affected tissue. Both treatments will be used in a multicentre, stratified, open, randomised, parallel-group phase III study to investigate and compare the efficacy and safety of the new PRRT to the Octreotide LAR treatment in preventing disease worsening and even reducing the amount of the tumour. The study will be funded by Advanced Accelerator Applications, France and will recruit patients from European countries and the USA. About 200 patients diagnosed with an inoperable, progressive, well-differentiated, midgut carcinoid tumour will be involved and treated either with 177Lu-DOTA0-Tyr3-Octreotate in combination with best supportive care (30 mg Octreotide LAR) administered at 8-week intervals or with 60 mg Octreotide LAR. Patients randomised to the PRRT group will take 30 mg Octreotide LAR every 4 weeks for a period of 1 year after completion of four 177Lu-DOTA0-Tyr3-Octreotate infusions. The patients in the other study group will receive 60 mg Octreotide LAR every 4 weeks for a period of 1.5 years. Following the treatment period, possible long-term side-effects and disease status of the patients in both treatment groups will be assessed over the next 3 years. Throughout the entire study, all patients will undergo clinical examinations of tumour-related symptoms, tumour assessment according to standard criteria, quality of life, etc. The tested PRRT is expected not only to slow down and even stop the tumour from getting worse prolonging overall survival but also to improve patients’ quality of life.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  12/NW/0251

• Date of REC Opinion

  25 Apr 2012

• REC opinion

  Further Information Favourable Opinion