Liver Metastases, Neuroendocrine Tumors
Conditions
Keywords
Neuroendocrine tumor, Liver metastases, 177Lu-DOTA-TATE, Safety, Kidney dosimetry, Dose escalation, Neuroendocrine tumors, with liver metastases.
Brief summary
By improved kidney dosimetry including biological effective dose and taking into account potential risk factors (especially for kidney toxicity), it might be possible to give an optimal and personalized treatment with 177Lu-DOTA-TATE to the patient with metastatic neuroendocrine tumor.
Interventions
DRUG177Lu-DOTA-TATE
177Lu-DOTA-TATE given as intravenous infusion given during 3-5 treatments. Evaluation is performed after every single cycle. Further more, evaluation is made after last cycle, and delivered cumulative dose to kidneys should be 27 Gy. Patients with stable disease or partial response, and without pronounced toxicity will continue treatment to a step 2, where additional 3-5 treatment cycles are given, with a cumulative dose to kidneys to 40 Gy.
Sponsors
Lund University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Step 1: * ECOG 0-2 * Histologically verified neuroendocrine tumors with a Ki67 of at least 20 % or at least 20 mitoses/high power fields. If the tissue on which this determination is based is several years old, the investigator should consider the option of acquiring a new determination, especially if the behaviour of the tumor has changed since diagnosis * Metastatic disease where complete resection is not considered possible or feasible * Measurable disease * Radiological disease progression during the last 14 months * The largest metastases should have an uptake of 111In-octreotide that is greater than the uptake in the liver by planar scintigraphy. Metastases that are small, or located centrally, can be evaluated by SPECT to enable a correct estimation of the relative uptake. The majority of the tumor burden must demonstrate an increased uptake for lutetium-treatment to be considered * Stable dose of somatostatin analogue for the past 3 months * Estimated survival more than 6 months * ANC more than 1.5 x 10 9/L * Bilirubin less than 1.5 x upper limit of normal * GFR more than 50 ml/min. * Signed written informed concent Step 2: * Continues to fulfill all of the inclusion criteria, and none of the
Exclusion criteria
, from step 1 * A maintained GFR (less than 40 % decrease compared to baseline AND GFR more than 50 ml/min) * The treatment in step 1 have been administered with a maximal interval of 12 weeks * Age under 70 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective tumor response after a cumulative kidney biologically effective dose (BED) of 27 +/- 2 Gy | 3 months after completed step 1 |
Secondary
| Measure | Time frame |
|---|---|
| Objective tumor response after receiving a cumulative BED to the kidneys of 40 +/- 2 Gy as per RECIST v 1.1 | 3 months after completing step 2 treatment |
Countries
Sweden
Outcome results
None listed