Best Therapy for Patients With Neuroendocrine Tumors
Conditions
Neuroendocrine Tumors
Conditions: official terms
Apudoma - Carcinoid Tumor - Neuroendocrine Tumors
Conditions: Keywords
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
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
Summary
A prospective observational study containing three arms comprising different therapeutic measures to treat patients with neuroendocrine tumors in advanced stages. The therapy arms include local ablative therapy such as TACE or SIRT, surgery and RFA with peptide receptor radiotherapy.
Detailed Description
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Zentralklinik Bad Berka
Bad Berka, Germany
Status: Recruiting
Start Date
November 2008
Completion Date
November 2012
Sponsors
Zentralklinik Bad Berka
Source
Zentralklinik Bad Berka
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page