In the Compete study, patients with inoperable GEP-NET - neuroendocrine tumors of the gastrointestinal tract or pancreas - are treated. This type of tumor belongs to a group of slow-growing, malignant tumors.
Aim of the study
The study investigates the drug effect on tumors of the gastrointestinal tract and pancreas. We are conducting this study to gain new insights into the efficacy, safety and tolerability of a new treatment option.
Who can take part?
Treatment of patients with well-differentiated, somatostatin receptor-positive, inoperable or metastatic neuroendocrine tumors (NETs) of gastroenterological or pancreatic origin
Procedure
During an inclusion visit, your investigator will ask you about your medical history and review your medical records. You will be asked to list your current medications, including herbal medicines, vitamin supplements and over-the-counter medicines. After you have signed your consent form, preliminary examinations will be carried out to determine whether you can take part in this study. Treatment with 177Lu-Edotreotide takes place on a total of 4 visits (day 0, day 90, day 180, day 270), on each of which you will remain in the clinic for at least 2 days. Each treatment day is divided into 3 parts: Pre-dose (= before dose administration), treatment, post-dose (= after dose administration). After each 177Lu-Edotreotide infusion, various examinations are scheduled (e.g. physical examination, blood samples, ECG and imaging examinations), which take place 24 hours and in the period from 72 to 96 hours after administration. These examinations include imaging of the liver with and without contrast medium as well as imaging of the three regions of the chest, abdomen and pelvic region using MRI or CT. The kidney is also regularly subjected to an imaging examination in order to counteract any radiation damage in good time. After the treatment phase, you will continue to come for outpatient examinations every 3 months until the end of the study. Treatment with everolimus involves monthly visits during the first 12 months, followed by 3-monthly visits until the end of the study. You come for an outpatient visit, receive all pre-dose examinations and can go home approx. 3 hours after taking the medication, when all examinations have been carried out (e.g. physical examination, blood samples, ECG). Tumor development is monitored every three months using imaging techniques (CT or MRI).
Compensation
None
Original study name
A prospective, randomized, controlled, open-label, multicenter, phase III study to evaluate the efficacy and safety of peptide receptor radionuclide therapy (PRRT) with 177Lu-edotreotide compared to targeted molecular therapy with everolimus in patients with unresectable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET)
BASEC number
2017-00466
Financial support from
ITM Solucin