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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004493
Receipt No. R000005372
Scientific Title Feasibility study of moderate dose of cisplatin-based chemotherapy with short hydration for advanced lung cancer
Date of disclosure of the study information 2010/11/01
Last modified on 2015/11/01

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Basic information
Public title Feasibility study of moderate dose of cisplatin-based chemotherapy with short hydration for advanced lung cancer
Acronym Feasibility study ofcisplatin-based chemotherapy with short hydration for advanced lung cancer
Scientific Title Feasibility study of moderate dose of cisplatin-based chemotherapy with short hydration for advanced lung cancer
Scientific Title:Acronym Feasibility study ofcisplatin-based chemotherapy with short hydration for advanced lung cancer
Region
Japan

Condition
Condition advanced lung cancer
Classification by specialty
Medicine in general Pneumology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate feasibility 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 cisplatin-based chemotherapy with short hydration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
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
Interventions/Control_2
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

Not applicable
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria pathologically proven squamous cell carcinoma

stage IV or stage III without suitability for curative treatment

aged 75 or younger

measurable tumor sites

no prior chemotherapy

no prior systemic anticancer therapy including palliative brain or bone irradiation within 2 weeks of proposed entry to this trial

ECOG PS of 0 to 1

appropriate organ function

acquisition of written informed
consent
Key exclusion criteria pts with active co-morbidities including severe conditions of heart diseases, gastric ulcers, infections, uncontrollable diabetes, psychlogicai diseases, hypertension, active interstitial and hearing loss.

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

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

pts with symptomatic brain metastases

pts who will receive CDDP of less than 60 mg/m²/day
Target sample size 45

Research contact person
Last 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 khotta@md.okayama-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Katsuyuki Hotta
Organization Okayama University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 2-5-1, Shikatacho, Okayama, Japan
TEL 086-223-7151
Homepage URL
Email khotta@md.okayama-u.ac.jp

Sponsor
Institute Okayama Lung Cancer Study Group
Institute
Department

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

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2010 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 11 Month 01 Day
Last modified on
2015 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005372

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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