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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-jRCTs051180149 |
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Date of registration:
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20/03/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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CBDCA plus PTX for NSCLC (squamous) with IP
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Scientific title:
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Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia - IP001 |
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Date of first enrolment:
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24/01/2013 |
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Target sample size:
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40 |
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Recruitment status: |
Complete |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCTs051180149 |
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Study type:
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Interventional |
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Study design:
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single arm study, open(masking not used), no treatment control/standard of care control, single assignment, treatment purpose
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Phase:
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2
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Contacts
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Name:
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Hidekazu
Suzuki |
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Address:
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3-7-1 Habikino, Habikino-shi, Osaka
583-8588
Osaka
Japan |
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Telephone:
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+81-72-957-2121 |
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Email:
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suzukih@ra.opho.jp |
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Affiliation:
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Osaka Habikino Medical Center |
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Name:
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Nobuyuki
Katakami |
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Address:
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5-1-4 Kohama, Takarazuka, Hyogo
665-0827
Hyogo
Japan |
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Telephone:
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+81-797-87-1161 |
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Email:
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nkatakami1954@gmail.com |
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Affiliation:
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Takarazuka City Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1) Squamous cell lung cancer
2) Age over twenty
3) Idiopathic interstitial pneumonia
4) Measurable lesion
5) ECOG performance status 0 or 1
6) Adequate organ function
WBC>=3000/mm3 and neutrophil count >=2000/mm3
Hgb>=10.0 g/dL, Plt>=100,000/mm3, T-bil=<1.5mg/dL, AST=<100 IU/L, ALT=<100 IU/L, CRN=<1.5mg/dL
7) PaO2>=60.0 torr or SpO2>=92.0 %( room air)
8) No symptoms from brain metastasis
9) Life expectancy > 3 months
10) Written informed consent
Exclusion criteria: 1) Secondly interstitial pneumonia.
2) History of acute exacerbation of interstitial pneumonia within 3 months.
3) Subacute progression of interstitial pneumonia within 3 months.
4) Using prednisolone or immune-suppressive agent.
5) Need to home oxygen therapy.
6) Past history of severe drug allergy.
7) Active infectious disease.
8) Severe complications
9) Symptomatic brain metastasis.
10) Uncontrollable effusion.
11) Active combined malignancy
12) Any ineligible case judged by physician.
Age minimum:
>= 20age old
Age maximum:
Not applicable
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Squamous cell lung cancer
Lung cancer
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Lung cancer
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Intervention(s)
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Carboplatin (AUC=5) given on day1 and paclitaxel (70mg/m2) given on days 1,8,15 every 4weeks until disease progression or unmanageable toxicity.
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Primary Outcome(s)
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Response rate
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Secondary Outcome(s)
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overall survival, progression free survival, time to treatment failure, adverse event
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Secondary ID(s)
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UMIN000018248
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Source(s) of Monetary Support
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Kobe City Medical Center General Hospital
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Takarazuka City Hospital
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Ethics review
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Status: Approval
Approval date: 08/03/2019
Contact:
ethics_nara@naramed-u.ac.jp
Nara Medical University Certified Review Board
+81-744-29-8835
ethics_nara@naramed-u.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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29/10/2021 |
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Date Completed:
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29/10/2020 |
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URL:
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