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

NCT ID: NCT01737216

Last Updated: 2012-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Lung Cancer

Keywords

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Aged patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Zoledronic acid plus First-line chemotherapy

Group Type EXPERIMENTAL

Zoledronic acid plus EP/TP

Intervention Type 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

First-line chemotherapy

Group Type ACTIVE_COMPARATOR

EP/TP

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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First-line chemotherapy

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hebei Tumor Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei Liu

Role: PRINCIPAL_INVESTIGATOR

Hebei Tumor Hospital

Locations

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Hebei Tumor Hospital

Shijiazhuang, Hebei, China

Site Status

Countries

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China

Other Identifiers

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Hebei Tumor Hospital

Identifier Type: REGISTRY

Identifier Source: secondary_id

HBTH201

Identifier Type: -

Identifier Source: org_study_id