UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013613 |
|---|---|
| Receipt number | R000010573 |
| Scientific Title | Phase II clinical trial of alternate-day therapy of S-1 plus carboplatin for squamous cell lung cancer. |
| Date of disclosure of the study information | 2014/04/03 |
| Last modified on | 2014/04/02 21:48:41 |
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Basic information
Public title
Phase II clinical trial of alternate-day therapy of S-1 plus carboplatin for squamous cell lung cancer.
Acronym
Phase II clinical trial of alternate-day therapy of S-1 plus carboplatin for squamous cell lung cancer.
Scientific Title
Phase II clinical trial of alternate-day therapy of S-1 plus carboplatin for squamous cell lung cancer.
Scientific Title:Acronym
Phase II clinical trial of alternate-day therapy of S-1 plus carboplatin for squamous cell lung cancer.
Region
| Japan |
Condition
Condition
squamous cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of alternate-day therapy of S-1 plus carboplatin for squamous cell lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Adverse event, Biomarker, Dose Intensity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Carboplatin plus alternative S-1
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Chemotherapy not enforcement cases of stage IV or stage IIIB clinical stage radical irradiation with a diagnosis of squamous cell carcinoma of the lung biopsy or by cytology is not possible.Patients with measurable disease.Performance Status is 0 or 1.WBC more than 4,000 uL,Neutrocyte more than 1,500/uL,Plate more than 100,000/uL,Hb more than 9.0 g/dL,AST/ALT less than 100 IU/L,Total bilirubin less than 1.5 mg/dL,eGFR more than 40 ml/min./1.73m2,SpO2 more than 94 percent.Cases can be expected survival of more than 12 weeks from the start of the administration date.
Key exclusion criteria
Case you are planning to radiation concurrent chemotherapy.In addition, patients who had made every irradiation in 2 weeks.Came into force the definitive operation or cases of enforcement plan.Cases are complicated by serious infections.Patients with brain metastases that have clinical symptoms.Cases with pericardial effusion storage chest or ascites requiring drainage.Patients with pulmonary fibrosis or interstitial pneumonia.Mental illness to be a clinical problem.Patients with overlapping cancer activity.Cases there is a possibility that pregnant women, nursing mothers, pregnant.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isobe Takeshi |
Organization
Shimane university Hospital
Division name
Division of Medical Oncology & Respiratory Medicine
Zip code
Address
89-1 enya-cho, izumo-city, Shimane-ken, Japan
TEL
0853-20-2580
smn70329@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koba Naoya |
Organization
Shimane university Hospital
Division name
Division of Medical Oncology & Respiratory Medicine
Zip code
Address
89-1 enya-cho, izumo-city, Shimane-ken, Japan
TEL
0853-20-2580
Homepage URL
smn70329@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane university Hospital
Institute
Department
Personal name
Funding Source
Organization
Shimane university Hospital, Division of Medical Oncology & Respiratory Medicine
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
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
| 2014 | Year | 04 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 05 | 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
| 2014 | Year | 04 | Month | 02 | Day |
Last modified on
| 2014 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010573
