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


N/A
18 Years
60 Years
Open (Enrolling)
Both
Liver, Metastasis, Neuroendocrine Tumors

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

tumor free survival

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Christine Wurst, Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of general-, visceral- and vascular surgery, University of Jena

Authority:

Germany: Ethics Commission

Study ID:

NEO-LEBE

NCT ID:

NCT01201096

Start Date:

September 2010

Completion Date:

September 2018

Related Keywords:

  • Liver
  • Metastasis
  • Neuroendocrine Tumors
  • neuroendocrine tumor
  • liver metastasis
  • peptide receptor therapy
  • gastro-entero-pancreatic system
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Neuroendocrine Tumors
  • Liver Neoplasms

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