Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments zoledronic acid plus ep/tp, ep/tp
Phase phase 2
Sponsor Hebei Tumor Hospital
Start date November 2012
End date January 2016
Trial size 100 participants
Trial identifier NCT01737216, HBTH201, Hebei Tumor Hospital

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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
(Active Comparator)
ep/tp First-line chemotherapy
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 Outcomes

Measure
Progression-free survival(PFS)
time frame: 1 year

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 70 years old.

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

Additional Information

Principal investigator Wei Liu
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Hebei Tumor Hospital.