Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | patients undergoing local ablative therapy such as transcatheter-arterial chemoembolization or selective interal radiotherapy | ||
| 2 | patients undergoing surgery or radiofrequency ablation | ||
| 3 | patients undergoing peptide receptor radiotherapy |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
patients with neuroendocrine tumors in a tertiary referal center
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dieter Hörsch, MD | Zentralklinik Bad Berka GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentralklinik Bad Berka | Bad Berka | 99437 | Germany |
Not provided
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| D009380 | Neoplasms, Nerve Tissue |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |