Neo-adjuvant Peptide Receptor Mediated Radiotherapy With 177Lutetium in Front of Curative Intended Liver Transplantation in Patients With Hepatic Metastasis of Neuroendocrine Tumors (NEO-LEBE)

University of Jena

Status: Unknown

Conditions: Metastasis; Neuroendocrine Tumors; Liver

Treatments: Procedure: Liver transplantation; Radiation: 177Lutetium

Study type: Observational

Funder types: Other

Identifiers

NCT01201096

NEO-LEBE

Details and patient eligibility

About

The purpose of this study is to show the tumor free long term survival of patients with isolated non-resectable liver metastases of neuroendocrine tumors after neo-adjuvant radio receptor treatment and following liver transplantation.

Full description

Matching patient will be treated neo-adjuvant at the hospital with 177 Lutetium peptide receptor radiotherapy in two following courses. After this treatment it will follow the liver transplantation within 9 month as postmortal or living donor liver transplantation.

Under certain conditions concerning the evaluation examinations patients can be included in the study.

Most important factors are no evidence of disease outside the liver, removed primary tumor, patients between 18 and 60 years, no curative surgical resection of the liver metastasis possible.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 to 60 years
• neuroendocrine Tumor with low or intermediate malignant histological appearance
• primary tumor removed, no extrahepatic tumor
• liver metastasis not resectable
• positive evaluation for liver transplantation
• primary tumor drained by vena porta
• tumor load within the liver < 50%
• stable disease after receptor therapy with 177 Lutetium for 6 month

Exclusion criteria

• prognostic relevant second tumor disease
• pregnancy
• undifferentiated neuroendocrine carcinoma (WHO II, G3)
• renal insufficiency > second degree
• progressive carcinoid conditioned heart disease (>NYHA II)
• Karnofsky-Index < 60

Trial design

50 participants in 1 patient group

peptide radioreceptor therapy and liver transplantation

Treatment:

Procedure: Liver transplantation

Radiation: 177Lutetium