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

Hebei Tumor Hospital

Status and phase: Unknown; Phase 2

Conditions: Lung Cancer

Treatments: Drug: EP/TP; Drug: Zoledronic acid plus EP/TP

Study type: Interventional

Funder types: Other

Identifiers

NCT01737216

Hebei Tumor Hospital (Registry Identifier)

HBTH201

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Zoledronic acid plus First-line chemotherapy

Experimental group

Treatment:

Drug: Zoledronic acid plus EP/TP

First-line chemotherapy

Active Comparator group

Treatment:

Drug: EP/TP