Pilot Study of Zoledronic Acid in Combination With First-... | NCT01737216

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

NCT01737216

Sponsor

Hebei Tumor Hospital

Status

Unknown status

Last Update Posted

Dec 31, 2012Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Lung Cancer

Interventions

Zoledronic acid plus EP/TP
EP/TP

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Hebei Tumor Hospital	Registry Identifier	Hebei Tumor Hospital

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Jan 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Nov 27, 2012

First Submission Date that Met QC Criteria

Nov 28, 2012

First Posted Date

Nov 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2012

Last Update Posted Date

Dec 31, 2012Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Zoledronic acid plus First-line chemotherapy	Experimental		Drug: Zoledronic acid plus EP/TP
First-line chemotherapy	Active Comparator		Drug: EP/TP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zoledronic acid plus EP/TP	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival(PFS)		1 year

Secondary Outcomes

Measure	Description	Time Frame
Overall survival(OS)		3 years
Bone mineral density(BMD)		1 year
Quality of life(QOL)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wei Liu	Hebei Tumor Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hebei Tumor Hospital		Shijiazhuang	Hebei	050011	China

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077211	Zoledronic Acid

Ancestor Terms

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided