UMIN-CTR Clinical Trial

Public title

Randomized phase II study of zoledronate administration schedule comparing every 4 weeks versus every 8 weeks for metastatic lung cancer with bone metastasis

Acronym

Zoledronate administration schedule P2 study

Scientific Title

Randomized phase II study of zoledronate administration schedule comparing every 4 weeks versus every 8 weeks for metastatic lung cancer with bone metastasis

Scientific Title:Acronym

Zoledronate administration schedule P2 study

Region

Japan

Condition

Primary lung cancer

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This randomized phase 2 study is conducted to compare bimonthly vs monthly zoledronate in lung cancer patients after 2 months of standard zoledronate therapy.
Primary endpoint: Time to first skeletal related events (SREs), Proportion of patients experiencing SREs, Types of SREs.

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Time to first skeletal related events (SREs), Proportion of patients experiencing SREs, Types of SREs

Key secondary outcomes

Proportion of patients experiencing SREs (first 6 months), Bone marker levels (NTX), Bone pain, Use of analgesics, Safety, Overall survival

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

International guidelines recommend treatment with bisphosphonates (including zoledronate) in cancer patients with bone metastasis. Standard treatment schedule is 4mg every 4 weeks. We adopted the schedule as a control arm.

Interventions/Control_2

In this study, an experimental arm is a less frequent regimen of zoledronate (4mg every 8 weeks) after 2 months of treatment at the standard dosing schedule.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Lung cancer patients with radiologically-proven osteolytic bone metastasis
2)Age >= 20 years
3)PS: 0 to 3
4)Estimated CCr: >= 30ml/min
5)Modified serum Ca: 8-11.5 mg/dl
6)Life expectancy of more than 4 months
7)Written informed consent

Key exclusion criteria

1)Patients with a history of intravenous bisphosphonate therapy
2)Uncontrolled co-morbidities and/or infectious diseases
3)Women who are pregnant, have a desire to bear children or in lactation
4)Recent (within 4 weeks) tooth extraction due to dental infection
5)Planned dental or jaw surgery (e.g., extraction, implants)
6)Any other current malignancy or malignancy diagnosed within the past five years.
7)Patients deemed unacceptable for inclusion to the study.

Target sample size

210

Name of lead principal investigator

1st name
Middle name
Last name	Nobuyuki Katakami M.D.

Organization

Institute of Biomedical Research and Innovation

Division name

Division of Integrated Oncology

Zip code

Address

2-2 Minatojima Minami-machi, Chuo-ku, Kobe

TEL

0783045200

Email

shuyoka@fbri.org

Name of contact person

1st name
Middle name
Last name	Shiro Fujita M.D.

Organization

Institute of Biomedical Research and Innovation

Division name

Division of Integrated Oncology

Zip code

Address

2-2 Minatojima Minami-machi, Chuo-ku, Kobe

TEL

0783045200

Homepage URL

Email

sfujita@fbri.org

Institute

Institute of Biomedical Research and Innovation

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

11

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2012

Year

11

Month

20

Day

Date of IRB

Anticipated trial start date

2012

Year

11

Month

21

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

11

Month

20

Day

Last modified on

2016

Year

01

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011014