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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01737216

Enrollment

100

Registered

2012-11-29

Start date

2012-11-30

Completion date

2016-12-31

Last updated

2012-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Aged, patients

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.

Interventions

DRUGZoledronic 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

DRUGEP/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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression-free survival(PFS)	1 year

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026