Neuroendocrine Tumours
Conditions
Brief summary
To evaluate, in patients with progressive neuroendocrine tumours who are not eligible to be treated with either surgery or chemotherapy at the moment of study inclusion, the efficacy of lanreotide Autogel in tumour growth stabilization.
Interventions
120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.
Sponsors
Ipsen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with histopathologic diagnosis of well-differentiated neuroendocrine tumour or carcinoma according to WHO classification * patients who, according to RECIST criteria (Response Evaluation Criteria in Solid Tumours) present measurable disease * patients with progressive disease in the previous 6 months before their inclusion in the study * patients with positive IN111 octreotide scintigraphy
Exclusion criteria
* patients with surgically removable localised disease * patients with progressive disease in the first six months of being diagnosed * patients with intestinal obstruction due to a carcinoid tumour * patients who have received treatment with somatostatin analogues during the 6 months before being included in the study * patients who have received treatment with radiotherapy, chemotherapy or interferon 4 weeks before being included in the study, or planned to receive these during the study * patients who have received treatment with liver artery embolisation or radiopharmaceuticals (endoradiotherapy) 12 weeks before being included in the study, or planned during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to disease progression (appearance of 1+ new lesions or increase >or= to 20% of sum of the longest diameters of target lesions compared to the lower sum of maximum diameters recorded since the start of the study). | Month 3, 6, 9, 12, 15, 18, 21 and 24 |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate efficacy related to tumour's partial or total response, biological disease markers response, symptomatic control, effect of treatment on patient's quality of life | Month 3, 6, 9, 12, 15, 18, 21 and 24 |
| Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel | Month 3, 6, 9, 12, 18, 21 and 24 |
| Tolerance | All visits |
Countries
Spain
Outcome results
None listed