NCT00815620

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2008

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

7.8 years

First QC Date

December 29, 2008

Last Update Submit

March 20, 2017

Conditions

Neuroendocrine Tumors

Keywords

neuroendocrine tumorstranscatheter arterial chemoembolizationselective internal radiotherapysurgeryradio-frequency ablationpeptide-receptor radiotherapyprogression-free survivalquality of lifeoverall survivalweighttime of hospitalization

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    2 years

Secondary Outcomes (1)

  • overall survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index

    2 years

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with neuroendocrine tumors in a tertiary referal center

You may qualify if:

  • 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

You may not qualify if:

  • Undifferentiated neuroendocrine carcinoma (WHO class III, TNM grading 3)
  • secondary tumor
  • advanced carcinoid heart disease requiring surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zentralklinik Bad Berka

Bad Berka, 99437, Germany

Location

MeSH Terms

Conditions

Neuroendocrine TumorsBody Weight

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dieter Hörsch, MD

    Zentralklinik Bad Berka GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant

Study Record Dates

First Submitted

December 29, 2008

First Posted

December 30, 2008

Study Start

November 1, 2008

Primary Completion

August 1, 2016

Study Completion

March 1, 2017

Last Updated

March 21, 2017

Record last verified: 2017-03

Locations

DE(1)