UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015293
Receipt number R000017790
Scientific Title Randomized phase II feasibility study of mannitol or furosemide hydration in moderate dose of cisplatin-based chemotherapy with short hydration for advanced non-small cell lung cancer
Date of disclosure of the study information 2014/10/01
Last modified on 2021/01/19 13:12:22

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Basic information

Public title

Randomized phase II feasibility study of mannitol or furosemide hydration in moderate dose of cisplatin-based chemotherapy with short hydration for advanced non-small cell lung cancer

Acronym

Randomized phase II feasibility study of mannitol or furosemide hydration in cisplatin-based chemotherapy with short hydration for advanced non-small cell lung cancer

Scientific Title

Randomized phase II feasibility study of mannitol or furosemide hydration in moderate dose of cisplatin-based chemotherapy with short hydration for advanced non-small cell lung cancer

Scientific Title:Acronym

Randomized phase II feasibility study of mannitol or furosemide hydration in cisplatin-based chemotherapy with short hydration for advanced non-small cell lung cancer

Region

Japan


Condition

Condition

advanced non small cell lung cancer

Classification by specialty

Medicine in general Pneumology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare feasibility of mannnitol or furosemide forced diuresis of cisplatin-based chemotherapy with short hydration

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

feasibility of mannnitol or furosemide forced diuresis of cisplatin-based chemotherapy with short hydration

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

to evaluate the proportion of renal toxicity in cisplatin-based chemotherapy with short hydration using mannitol

Interventions/Control_2

to evaluate the proportion of renal toxicity in cisplatin-based chemotherapy with short hydration using furosemide

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

pathologically proven non small cell lung cancer

stage IV or stage III without suitability for curative treatment or postoperative reccurent case

combination chemotherapy using cisplatin plus 3rd generation anticancer drug

at the age of 20 to 75

measurable tumor sites

no prior chemotherapy

no prior systemic anticancer therapy including palliative brain or bone irradiation within 1 week of proposed entry to this trial

ECOG PS of 0 to 1

appropriate organ function

acquisition of written informed
consent

Key exclusion criteria

1. pts who will receive CDDP of less than 75 mg/m&sup2;/day

2. pts with active co-morbidities including severe conditions of heart diseases, cerebrovascular diseases, gastric ulcers, severe infections, uncontrollable diabetes, psychlogicai diseases, and hearing loss.

3. pts with active interstitial lung diseases.

4. pts with symptomatic brain metastases.

5. pts with active other cancers detected within the past 3 years.

6. pts with massive pleural and cardiac effusion and ascites that need to be immediately treated

7. pts with using oral diuretics

8. pts who can not drink water more than 1L/day.

Target sample size

66


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuyuki Kiura

Organization

Okayama University Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

2-5-1, Shikatacho, Okayama, Japan

TEL

086-223-7151

Email

s_wolfjp@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Go Makimoto

Organization

Okayama University Hospital

Division name

Department of Repiratory Medicine

Zip code


Address

2-5-1, Shikatacho, Okayama, Japan

TEL

086-223-7151

Homepage URL


Email

s_wolfjp@yahoo.co.jp


Sponsor or person

Institute

Okayama University Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

岡山大学病院(岡山県)


Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 10 Month 01 Day

Date of IRB

2014 Year 10 Month 01 Day

Anticipated trial start date

2014 Year 11 Month 01 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 09 Month 30 Day

Last modified on

2021 Year 01 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017790


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name