Best Therapy for Patients With Neuroendocrine Tumors
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.
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
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Conditions
Neuroendocrine Tumors
Location
Zentralklinik Bad Berka
Bad Berka
Germany
99437
Status
Recruiting
Source
Zentralklinik Bad Berka
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00815620
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Neuroendocrine Tumors
Tumors whose cells possess secretory granules and originate from the neuroectoderm, i.e., the cells of the ectoblast or epiblast that program the neuroendocrine system. Common properties across most neuroendocrine tumors include ectopic hormone production (often via APUD CELLS), the presence of tumor-associated antigens, and isozyme composition.
Carcinoma, Neuroendocrine
A group of carcinomas which share a characteristic morphology, often being composed of clusters and trabecular sheets of round "blue cells", granular chromatin, and an attenuated rim of poorly demarcated cytoplasm. Neuroendocrine tumors include carcinoids, small ("oat") cell carcinomas, medullary carcinoma of the thyroid, Merkel cell tumor, cutaneous neuroendocrine carcinoma, pancreatic islet cell tumors, and pheochromocytoma. Neurosecretory granules are found within the tumor cells. (Segen, Dictionary of Modern Medicine, 1992)
Synaptophysin
A 38-kDa integral membrane glycoprotein of the presynaptic vesicles in neuron and neuroendocrine cells. It is expressed by a variety of normal and neoplastic neuroendocrine cells and is therefore used as an immunocytochemical marker for neuroendocrine differentiation in various tumors. In ALZHEIMER DISEASE and other dementing disorders, there is an important synapse loss due in part to a decrease of synaptophysin in the presynaptic vesicles.
Neuroendocrine Secretory Protein 7b2
An acidic protein found in the NEUROENDOCRINE SYSTEM that functions as a molecular chaperone for PROPROTEIN CONVERTASE 2.
Carcinoid Tumor
A usually small, slow-growing neoplasm composed of islands of rounded, oxyphilic, or spindle-shaped cells of medium size, with moderately small vesicular nuclei, and covered by intact mucosa with a yellow cut surface. The tumor can occur anywhere in the gastrointestinal tract (and in the lungs and other sites); approximately 90% arise in the appendix. It is now established that these tumors are of neuroendocrine origin and derive from a primitive stem cell. (From Stedman, 25th ed & Holland et al., Cancer Medicine, 3d ed, p1182)
Clinical Trials
Clinical and Pathologic Studies in Neuroendocrine Tumors
This research involves the study of neuroendocrine tumors in order to better understand how the disease grows and spreads. This study requires will use tissue collected from from biopsies...
Phase II Capecitabine, Oxaliplatin & Bevacizumab for Metastatic / Unresectable Neuroendocrine Tumors
Given the lack of other viable treatment options for metastatic neuroendocrine tumors, contrasted with our positive anecdotal experience, and the relative tolerability of the treatment reg...
ProGRP, CgA, NSE and TUM2-PK in in Patients With Neuroendocrine Tumors
The purpose of this study is to determine whether monitoring of levels of Serological Markers ProGRP, CgA, NSE and Pyruvate Kinase M2 are effective in the Evaluation of Diagnosis, Monitori...
High Dose I-131 Metaiodobenzylguanidine(MIBG) for Metastatic Neuroendocrine Tumors
The goal of this clinical research study is to learn if I-131 Metaiodobenzylguanidine (MIBG) can shrink or slow the growth of the tumor(s) in patients with metastatic neuroendocrine tumors...
Lithium for Low-Grade Neuroendocrine Tumors
The purpose of this study is to learn more about the effectiveness and side effects of lithium treatment for subjects with low-grade neuroendocrine tumors.
PubMed Articles
PAX (paired box) genes encode a family of transcription factors important for organogenesis. Recently, PAX8 has been recognized as a potential immunohistochemical marker of pancreatic neuroendocrine t...
Neuroendocrine tumors are considered rare tumors: recently an increased incidence and an improvement in survival were described. We explore distribution, incidence and survival of neuroendocrine tumor...
The molecular pathogenesis of gastroenteropancreatic neuroendocrine tumors is largely unknown. We hypothesize that gastroenteropancreatic neuroendocrine tumors are heterogeneous with regard to these s...
Neuroendocrine neoplasms of the digestive system are classified by current World Health Organization (WHO) guidelines as G1 and G2 neuroendocrine tumors (NET) as well as neuroendocrine carcinoma (NEC)...
BACKGROUND: Neuroendocrine tumors are rare neoplasms arising from neural and epithelial origin. METHODS AND RESULTS: The case records of 4 patients with the diagnosis of neuroendocrine laryngeal tumor...
