Patients with neuroendocrine neoplasms origin from the gastrointestinal tract, pancreas, adrenal glands (pheochromocytomas.), lungs, or from unknown primary site MedDRA version: 21.0 Level: LLT Classification code 10062476 Term: Neuroendocrine tumor System Organ Class: 100000004864
Conditions
Interventions
Product Name: Lu-177-DOTATOC
Pharmaceutical Form: Infusion
INN or Proposed INN: Lu-177
CAS Number: 14265-75-9
Current Sponsor code: Lu-177
Other descriptive name: LUTETIUM LU-177
Concentration unit: G
Sponsors
Anne Kirstine Arveschoug
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients > 18 years of age 2. NEN confirmed by histology 3. Clinical, PET/CT or CT proven progression despite standard treatment with somatostatin analogues, targeted therapy (Everolimus, sunitinib), chemotherapy (STZ/5-FU, temozolomide/capecitabine) OR intolerable side effects caused by these standard treatment OR unmanageable carcinoid symptoms. 4. WHO/ ECOG Performance Status of 0-2. 5. Life expectancy > 6 months 6. Uptake higher than liver in primary tumor or metastases on Ga-DOTATOC PET/CT (Krenning 3 or 4), if the scan is more than 3 months old at inclusion time, a new scan should be done. 7. Adequate organ function as defined by: • Adequate kidney function: Standard glomerular filtration rate >30 ml/min/m2 measured by Tc-DTPA clearance • Adequate bone marrow function: • WBC = 2.0 x 109/L • Platelets = 100 x 109/L • Hb = 6 mmol/l (=9.67 g/dL ) • No evidence of significant liver disease: • Serum bilirubin 20g/L 8. Willingness and ability to comply with scheduled visits for SPECT/CT scans, treatment plans, laboratory tests and other study procedures. 9. Written informed consent obtained prior to any screening procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Tumor amenable to surgery and/or radiofrequency ablation. 2. Patients who are unable to stay isolated for 24 hours 3. Previous PRRT 4. Female patients who are pregnant or lactating. Women who are of childbearing potential (defined as all women physiologically capable of becoming pregnant) have to practice an effective method of contraception/birth control. Fertile female patients have to take a urinary pregnancy test, to ensure that they are not pregnant, before they can enter the study. After entering the study, they have to use effective contraception during the study period and 6 months after. Effective contraception methods include: • Use of oral, injected or implanted hormonal methods of contraception or • Placement of an intrauterine device (IUD) or intrauterine system (IUS) • Barrier methods of contraception: condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository can be used if hormonal contraception is not tolerated. Both have to be used at the same time. • Total abstinence or patient sterilization (male or female) 5. Male patients are not allowed to conceive pregnancy for 6 months after last treatment cycle 6. Patients with meningioma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: •Difference in progression free survival between NEN patients treated with dosimetry based versus standard PRRT. Defined as time from randomization to documented disease progression or death by any cause. ;Secondary Objective: Our secondary endpoints are: •Difference in tumor dose between dosimetry based and standard PRRT treatment groups •Difference in kidney toxicity between dosimetry based and standard PRRT treatment groups, measured by creatine, eGFR, cystatin-c, Tc-DTPA clearance, and kidney fibrosis markers PRO-6, C3M and LAMC1. •Difference in bone marrow function between dosimetry based and standard PRRT treatment groups, measured by hemoglobin, white blood cells, platelets. •Difference in subjective side effects between dosimetry based and standard PRRT treatment groups, evaluated by questionnaire. •Difference in quality of life between dosimetry based and standard PRRT treatment groups, evaluated by questionnaire EORTC QLQ-30 and QLQ-GI.NET21. •Difference in overall survival between dosimetry based and standard PRRT treatment groups.;Primary end point(s): •Difference in progression free survival between NEN patients treated with dosimetry based versus standard PRRT. Defined as time from randomization to documented disease progression or death by any cause, evaluated by CT, RECIST 1.1.;Timepoint(s) of evaluation of this end point: 12 months after LPLV | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Difference in tumor dose between dosimetry based and standard PRRT treatment groups • Difference in kidney toxicity between dosimetry based and standard PRRT treatment groups, measured by creatine, eGFR, cystatin-c, Tc-DTPA clearance, and kidney fibrosis markers PRO-6, C3M and LAMC1. • Difference in bone marrow function between dosimetry based and standard PRRT treatment groups, measured by hemoglobin, white blood cells, platelets. • Difference in subjective side effects between dosimetry based and standard PRRT treatment groups, evaluated by questionnaire. • Difference in quality of life between dosimetry based and standard PRRT treatment groups, evaluated by questionnaire EORTC QLQ-30 and QLQ-GI.NET21. • Difference in overall survival between dosimetry based and standard PRRT treatment groups. ;Timepoint(s) of evaluation of this end point: Some can be evaluated right af LPLV and some several year after depending on how long the patients survive. | — |
Countries
Denmark
Contacts
Public ContactAnne Kirstine Arveschoug
Anne Kirstine Arveschoug
Outcome results
None listed