Best Therapy for Patients With Neuroendocrine Tumors

NCT ID: NCT00815620

Last Updated: 2017-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2017-03-31

Brief Summary

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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

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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

Conditions

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Neuroendocrine Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

patients undergoing local ablative therapy such as transcatheter-arterial chemoembolization or selective interal radiotherapy

No interventions assigned to this group

2

patients undergoing surgery or radiofrequency ablation

No interventions assigned to this group

3

patients undergoing peptide receptor radiotherapy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zentralklinik Bad Berka

OTHER

Sponsor Role lead

Responsible Party

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Dieter Hoersch MD

Senior consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dieter Hörsch, MD

Role: PRINCIPAL_INVESTIGATOR

Zentralklinik Bad Berka GmbH

Locations

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Zentralklinik Bad Berka

Bad Berka, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ZBB-NET-1

Identifier Type: -

Identifier Source: org_study_id

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