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Completed

NCT Number: NCT00762346

Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis

A multicenter prospective study to assess the efficacy and safety of ZOMETA® in treatment of high-level NTX non small cell lung cancer with bone metastasis.

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Key information

Conditions

Non Small Cell Lung Cancer Bone Metastases Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung High NTX Level Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

cancer center, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18
  • Histologically confirmed non-small cell cancer
  • One bone metastasis at least confirmed by image(X ray, CT or others)
  • NTX > 50nM BCE/mM creatinine
  • Life expectancy > 6 M
  • ECOG <= 2
  • Signed ICF

Exclusion criteria

  • Women who are pregnant or in lactation
  • Patients with hyperostosis with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled
  • Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
  • Severe co-morbidity of any type that may interfere with assessment of the patient for the study -

Treatment and study plan

Zometa

Drug

zometa 4mg i.v. every 4 weeks for up to 2 years

Primary outcomes

  1. Skeleton-related event

    Time frame: 2 years

Secondary outcomes

  1. OS

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Novartis

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Sep 30, 2008
Registry last updated
Dec 10, 2013

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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