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Pilot Study of Zoledronic Acid in Combination With First-line Chemotherapy in Aged Patients With Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hebei Tumor Hospital
ClinicalTrials.gov Identifier:
NCT01737216
First received: November 27, 2012
Last updated: December 28, 2012
Last verified: November 2012

November 27, 2012
December 28, 2012
November 2012
January 2016   (final data collection date for primary outcome measure)
Progression-free survival(PFS) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01737216 on ClinicalTrials.gov Archive Site
  • Overall survival(OS) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Bone mineral density(BMD) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Quality of life(QOL) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Pilot Study of Zoledronic Acid in Combination With First-line Chemotherapy in Aged Patients With Lung Cancer
Not Provided

Pilot study of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer. The purpose is to assess the effects of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer on bone mineral density gain in the lumbar spine and total hip.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Lung Cancer
  • Drug: Zoledronic acid plus EP/TP
    Drug:EP/TP+Zoledronic acid EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles Zoledronic acid 4mg d1 every 3 months until bone metastasis, 4mg d1 every 1 month until progression
  • Drug: EP/TP
    Drug:EP/TP EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles
    Other Name: First-line chemotherapy
  • Experimental: Zoledronic acid plus First-line chemotherapy
    Intervention: Drug: Zoledronic acid plus EP/TP
  • Active Comparator: First-line chemotherapy
    Intervention: Drug: EP/TP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2016
January 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed informed consent form
  • Age ≥70 years
  • Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
  • Histologically or cytologically confirmed lung cancer
  • Did not receive bisphosphonate treatment

Exclusion Criteria:

  • Appear relapse and metastasis
  • receive other bisphosphonate treatment
  • Active or uncontrolled infection
  • Pregnant or lactating women
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01737216
HBTH201, Hebei Tumor Hospital
Not Provided
Hebei Tumor Hospital
Hebei Tumor Hospital
Not Provided
Principal Investigator: Wei Liu Hebei Tumor Hospital
Hebei Tumor Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP