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Best Therapy for Patients With Neuroendocrine Tumors

18 Years
90 Years
Open (Enrolling)
Neuroendocrine Tumors

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Trial Information

Best Therapy for Patients With Neuroendocrine Tumors

Study design:

Prospective observational study comparing ablative measures as TACE or SIRT with surgery/RFA
and with peptide receptor radio-therapy in patients with advanced well-differentiated
neuroendocrine tumors with lymph node or distant metastases (N1, M1) Prospective evaluation
Primary end points: time to progression Secondary end points: survival, quality of life
(EORTC-QLQ30), weight, time of hospitalization, Karnofsky index) Non-randomized cohort study
Number of patients needed in all groups: 70 per group, 210 overall Evaluation of response to
therapy every 3-6 months by imaging, clinical status, weight, quality of life,
Karnofsky-index Cross-over allowed if therapy changes

Inclusion Criteria:

- Biopsy-proven neuroendocrine tumor (WHO class I-II, TNM grading 1-2)

- Advanced disease with lymph node or distant metastases (N1, M1) undergoing
cytoreduction by surgery/local ablative therapy or peptide receptor radiotherapy

- curative intent of all therapies possible

Exclusion Criteria:

- Undifferentiated neuroendocrine carcinoma (WHO class III, TNM grading 3)

- secondary tumor

- advanced carcinoid heart disease requiring surgery

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

progression-free survival

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Dieter Hörsch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zentralklinik Bad Berka GmbH


Germany: Ministry of Health

Study ID:




Start Date:

November 2008

Completion Date:

November 2012

Related Keywords:

  • Neuroendocrine Tumors
  • neuroendocrine tumors
  • transcatheter arterial chemoembolization
  • selective internal radiotherapy
  • surgery
  • radio-frequency ablation
  • peptide-receptor radiotherapy
  • progression-free survival
  • quality of life
  • overall survival
  • weight
  • time of hospitalization
  • Neuroendocrine Tumors