Comparison of 4-weekly vs 8-weekly Zoledronate for Lung Cancer

JRCT ID: jRCTs061180054

Registered date:14/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Lung cancer with bone metastasis
• Date of first enrollment: 28/12/2012
• Target sample size: 210
• Study type: Interventional

Intervention(s)

Arm A: zoledronic acid 4mg/body given on day 1 every 4 weeks(+-1 week) until SRE or unmanageable toxicity
Arm B: zoledronic acid 4mg/body given on day 1 every 8 weeks(+-2 weeks) until SRE or unmanageable toxicity

Outcome(s)

• Primary Outcome: Time to first SRE, type and incidence of SREs at 12 months interval

Secondary Outcome

1) Percentage of patients who develops SREs at 6 months interval
2) Change of serum NTX
3) Change of pain scale
4) Change of analgesic use
5) Incidence of adverse events
6) Overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Temporary inclusion criteria
1) Documented bone metastasis
2) Age >=20 years old
3) PS (ECOG) 0-3
4) Estimated creatinine clearance 30 ml/min=<
5) Corrected serum calcium 8 mg/dL=< and 11.5 mg/dL>
6) Expected life expectancy 4 months>=
7) Written informed consent
Main inclusion criteria
1) PS 0-3
2) Estimated creatinine clearance 30 ml/min=<
3) Corrected serum calcium 8 mg/dL=< and 11.5 mg/dL>
4) After two courses of zoledronic acid

Exclude criteria

At temporary enrolment
1) History of intravenous bisphosphonate
2) Uncontrollable complication or active infection
3) Pregnant, unwilling to practice contraception during the study, or lactating female
4) Tooth extraction, or active dental infection within 4 weeks
5) Plan to have tooth extraction or jaw surgery
6) Multiple primary cancers with disease-free period less than 1 year, except carcinoma in situ or intra mucosal disease cured by local therapy
7) Medically unfit patient judged by investigator
At main enrollment
1) Uncontrollable complication or active infection
2) Pregnant, unwilling to practice contraception during the study, or lactating female
3) Plan to have tooth extraction or jaw surgery
4) Multiple primary cancers with disease-free period less than 1 year, except carcinoma in situ or intra mucosal disease cured by local therapy
5) Medically unfit patient judged by investigator

Related Information

• Primary Sponsor: Katakami Nobuyuki
• Source(s) of Monetary Support: Kobe City Medical Center General Hospital,Takarazuka City Hospital
• Secondary ID(s): UMIN000009369