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A Multicenter Phase II-Study Evaluating Efficacy and Safety of 177Lu-DOTA-TATE Based on Kidney-Dosimetry in Patients With Disseminated Neuroendocrine Tumors

Phase 2
18 Years
70 Years
Open (Enrolling)
Neuroendocrine Tumors, Liver Metastases

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Trial Information

A Multicenter Phase II-Study Evaluating Efficacy and Safety of 177Lu-DOTA-TATE Based on Kidney-Dosimetry in Patients With Disseminated Neuroendocrine Tumors

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

- 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

- The treatment in step 1 have been administered with a maximal interval of 12 weeks

- Age under 70 years

Exclusion Criteria:

Step 1:

- Performance Status ECOG 3-4

- Proliferation index (Ki67) more than 20 % or more than 20 mitoses/hpf

- Loco-regional treatment during the last 3 months involving all of the measurable

- Chemotherapy during the last 3 months, or longer if persisting toxicity exists.
Earlier treatment with mTORi or TKI is permitted

- Other concommitant nephrotoxic treatment

- Modifications of the somatostatine dose in the last 3 months

- Serious heart disease

- Previous radiotherapy including more than 25 % of active bone marrow volume

- Pregnancy and lactation

- Extensive liver metastases (more than 50 % of liver volume)

- Symptomatic CNS metastases requiring corticosteroid treatment

- Ongoing treatment with interferon. This treatment should be suspended a minimum of 4
weeks before treatment with 177Lu-DOTA-TATE, or longer if there is persisting signs
of toxicity

- Patients who have another metastatic tumor diagnosis

Step 2:

- Progressive disease since start of study treatment

- Organ toxicity grade 3-4 during step 1

- Serious hematological toxicity during previous treatment cycles (ANC less than 0.5 x
10 9 or platelets less than 50.0 x 10 9)

- Longstanding diabetes (more than 8 years). Patients with a well-controlled diabetes
with a history of less than 8 years and a blood pressure less than 130/80 and no
albuminuria (albumin/creatinine index)can be included

- Hypertension, i.e. more than 160/90 (for diabetics more than 130/80).
Antihypertensive pharmacological treatment is permitted as long as there is no
manifest albuminuria

- Previous liver embolisation

- Previous chemotherapy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response after a cumulative kidney biologically effective dose (BED) of 27 +/- 2 Gy

Outcome Time Frame:

3 months after completed step 1

Safety Issue:


Principal Investigator

Jan Tennvall, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology, Lund University Hospital


Sweden: Medical Products Agency

Study ID:

EudraCT number: 2011-000240-16



Start Date:

October 2011

Completion Date:

October 2018

Related Keywords:

  • Neuroendocrine Tumors
  • Liver Metastases
  • Neuroendocrine tumor
  • Liver metastases
  • 177Lu-DOTA-TATE
  • Safety
  • Kidney dosimetry
  • Dose escalation
  • Neuroendocrine tumors, with liver metastases.
  • Neoplasm Metastasis
  • Neuroendocrine Tumors
  • Liver Neoplasms