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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-UMIN000015929 |
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Date of registration:
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12/12/2014 |
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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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Prospective observational study of Idiopathic pulmonary fibrosis with Non-small-cell lung cancer(LOGIK0603)
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Scientific title:
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Prospective observational study of Idiopathic pulmonary fibrosis with Non-small-cell lung cancer(LOGIK0603) - Prospective observational study of Idiopathic pulmonary fibrosis with Non-small-cell lung cancer(LOGIK0603) |
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Date of first enrolment:
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2007/05/10 |
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Target sample size:
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60 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018311 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Noriyuki Ebi |
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Address:
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3-83 Yoshio-machi Iizuka-shi Fukuoka,Japan
Japan |
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Telephone:
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0948-22-3800 |
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Email:
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nebi1@aih-net.com |
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Affiliation:
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Iizuka Hospital Department of Respiratory Medicine |
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Name:
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Noriyuki Ebi |
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Address:
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3-83 Yoshio-machi Iizuka-shi Fukuoka,Japan
Japan |
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Telephone:
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0948-22-3800 |
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Email:
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nebi1@aih-net.com |
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Affiliation:
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Iizuka Hospital Department of Respiratory Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Patients with suspicion of exacerbation of idiopathic pulmonary fibrosis (increase in such as LDH, KL-6, SP-A, SP-D, so on). 2) Patient with superior vena cava syndrome. 3) Patient with the history of severe drug allergy. 4) Patient with pleural effusion, ascites, and pericardial effusion need for treatment of such as drainage. 5) Patient with severe infection and other severe complications (gastrointestinal hemorrhage, heart disease, etc). 6) Patient with symptomatic brain metastasis. 7) Patients with steroid administration. 8) Patient with active double cancer. 9) Patient with diabetes hard to control. 10) Unstable psychic disorder. 11) Pregnant or breast-feeding females. 12) Inappropriate patients for this study judged by the physicians. In group B, to confirm hypersensitivity to polyoxyethylene castor oil (Cremophor EL) product (such as cyclosporine), curing caster oil product (such as injectable vitamin), and alcohol hypersensitivity.
Age minimum:
20years-old
Age maximum:
75years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Idiopathic pulmonary fibrosis
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Intervention(s)
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Carboplatin/paclitaxel combination therapy (dosage and administration) Paclitaxel (PAC):175-200mg/m2 at day1 and carboplatin (CBDCA): AUC 5-6min.mg/mL at day1 are administered and repeated every 21 days as 1 course and the treatment is aimed for more than 3 courses. *The study is discontinued at that point if it becomes PD.
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Primary Outcome(s)
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Frequency of acute exacerbation of idiopathic pulmonary fibrosis
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Secondary Outcome(s)
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Frequency of acute exacerbation of idiopathic pulmonary fibrosis and death rate about the patient treated with anticancer drug. Grading and frequency of other adverse event (CTCAE ver.3.0 Japanese edition/JCOG/JSCO) and response rate.
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Source(s) of Monetary Support
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Clinical Research Support Center Kyushu
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Ethics review
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Status: YES
Approval date:
Contact:
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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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Date Completed:
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22/06/2012 |
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URL:
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