Pilot Study of Zoledronic Acid in Combination With First-line Chemotherapy in Aged Patients With Lung Cancer
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Zoledronic acid plus EP/TP
EP/TP
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring Aged, patients
Eligibility Criteria
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
Sites / Locations
- Hebei Tumor Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Zoledronic acid plus First-line chemotherapy
First-line chemotherapy
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival(PFS)
Secondary Outcome Measures
Overall survival(OS)
Bone mineral density(BMD)
Quality of life(QOL)
Full Information
NCT ID
NCT01737216
First Posted
November 27, 2012
Last Updated
December 28, 2012
Sponsor
Hebei Tumor Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01737216
Brief Title
Pilot Study of Zoledronic Acid in Combination With First-line Chemotherapy in Aged Patients With Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Tumor Hospital
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Aged, patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Zoledronic acid plus First-line chemotherapy
Arm Type
Experimental
Arm Title
First-line chemotherapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid plus EP/TP
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
EP/TP
Other Intervention Name(s)
First-line chemotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression-free survival(PFS)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall survival(OS)
Time Frame
3 years
Title
Bone mineral density(BMD)
Time Frame
1 year
Title
Quality of life(QOL)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Liu
Organizational Affiliation
Hebei Tumor Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebei Tumor Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of Zoledronic Acid in Combination With First-line Chemotherapy in Aged Patients With Lung Cancer
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