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Completed

NCT Number: NCT00815620

Best Therapy for Patients With Neuroendocrine Tumors

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.

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Key information

Conditions

Neuroendocrine Tumors Body Weight Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zentralklinik Bad Berka

Bad Berka, 99437, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. progression-free survival

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Zentralklinik Bad Berka

Other

Registry information

Acronym: BESTTHERAPYNET

Important dates

Study start
2008
Primary completion
2016
Study completion
2017
First posted
Dec 30, 2008
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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