Conditions: Gastroenteropancreatic Neuroendocrine Tumors
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 57
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the efficacy and tolerability of the combination of Lanreotide Autogel 120 mg and Temozolomide in patients with progressive gastro-entero-pancreatic neuroendocrine tumours (GEP-NET) graded as G1 or G2 (G1/G2). All progressive tumours classified according to Response Evaluation Criteria In Solid Tumours (RECIST, 1.1).

Detailed description:

Arms:
arm 1: Combination phase for first 6 months: Lanreotide Autogel 120 mg and Temozolomide.

Followed by either 6 months Lanreotide Autogel 120 mg maintenance or 6 months of no treatment.

Interventions: intervention 1: Lanreotide Autogel 120 mg intervention 2: Temozolomide (TMZ)
Intervention descriptions: intervention 1: Lanreotide Autogel 120 mg subcutaneous (s.c) - injection, every 28 days (+/-2 days). intervention 2: Temozolomide capsule (variable dose). 150 mg/m2 per day for 5 days in the first month. 200 mg/m2 per day for 5 days in months 2, 3, 4, 5 and 6.

Protocol document: