Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||19 Years and Over|
Inclusion Criteria:1. Histopathologic diagnosis of gastro-entero-pancreatic neuroendocrine tumor, well differentiated G1
- - G2 (ki67≤20%) and G3 (ki67≤50%) 2.
Exclusion Criteria:1. Ki 67 index > 50% 2. FDG PET negative 3. Patients treated with chemotherapy and therapeutic radiotherapy within 6 weeks 4. More then 25% body surface radiotherapy 5. Patients treated with previous radiometabolic therapy with an adsorbed dose to the kidney more than 23 Gy and 1,2 Gy for the bone marrow or as surrogate of dosimetry, a Total Cumulative Activity (TCA) of >250 millicurie (mCi) of 90Y dotatoc or >800 (mCi) of 177Lutethium (177Lu) dotatate 6. All acute toxic effects of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to a grade ≤ 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) 7. Life expectancy minor than 6 months. 8. ECOG performance status >2 9. Participation in another clinical trial with any investigational agents within 30 days prior to study screening. 10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 11. History of allergic reactions attributed to compounds of similar chemical or biologic composition 12. Known dihydropyrimidine dehydrogenase (DPD) deficiency. 13. Known hypersensitivity to Octreotide and/or Lanreotide, and/or somatostatin correlate peptides 14. Known hypersensitivity to capecitabine or to any of its components 15. Known hypersensitivity to 5
- - fluorouracil.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Giovanni Paganelli, MD|
|Principal Investigator Affiliation||IRST IRCCS, Meldola (FC)|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Gastro-entero-pancreatic Neuroendocrine Tumors|
This is a randomized phase II, parallel group study. Patients with gastro-entero-pancreatic neuroendocrine tumors (GEP-NET) well differentiated G1
- - G2 (ki67≤ 20%) and G3 (ki67≤ 50%), SSR positive and 18-fluorodeoxyglucose (FDG) positive will be enrolled in the study and will be randomly assigned to 2 different arms: - Arm Lu-PRRT-Cap: oral low dose of capecitabine in association with Lu-PRRT (at 3.7 Gbq per cycle x 7 cycles) followed by long acting octreotide or lanreotide (SS-LAR); OR - Arm Lu-PRRT: Lu-PRRT (at 3.7Gbq per cycle x 7 cycles) followed by SS-LAR.
Experimental: Arm Lu-PRRT-Cap
Arm Lu-PRRT-Cap: oral low dose of capecitabine in association with Lu-PRRT (at 3.7 Gbq per cycle x 7 cycles) followed by long acting octreotide or lanreotide (SS-LAR)
Experimental: Arm Lu-PRRT
Arm Lu-PRRT: Lu-PRRT (at 3.7Gbq per cycle x 7 cycles) followed by long acting octreotide or lanreotide (SS-LAR)
Drug: - Capecitabine
oral low dose of capecitabine
Drug: - Lu-PRRT
Lu-PRRT (at 3.7Gbq per cycle x 7 cycles)
Drug: - SS-LAR
long acting octreotide or lanreotide
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.