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OpenTrials
Completed

NCT Number: NCT00765687

Screening Non Small Cell Lung Cancer With Bone Metastasis and Efficacy and Safety Research of Receiving Bisphosphonates

A multicenter Prospective Study to assess the screening methods, parameter of NTX and the efficacy and safety of zoledronic acid treatment in addition to anti-tumor therapy in patients of non-small cell cancer with bone metastasis in china.

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Key information

Conditions

Non-small Cell Lung Cancer Bone Metastases Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung 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

SunYat-senU

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age >18, either sex
  • Histologically confirmed non-small cell cancer
  • One bone metastasis at least confirmed by image(X ray,CT or others)
  • Without receiving zoledronic acid
  • 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

bisphosphates

Drug

any bisphosphate, repeated every 4 weeks for up to 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily

Primary outcomes

  1. Skeleton-related event

    Time frame: 24 months

Secondary outcomes

  1. overall survival

    Time frame: 24 months

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Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Novartis

Registry information

Official study title

A Multi-center Observational Clinical Study of Screening of Non-small-cell Lung Cancer With Bone Metastasis and Efficacy and Safety of Those Receiving Bisphosphonates

Acronym: BLEST

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Oct 3, 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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