UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015929 |
|---|---|
| Receipt number | R000018311 |
| Scientific Title | Prospective observational study of Idiopathic pulmonary fibrosis with Non-small-cell lung cancer(LOGIK0603) |
| Date of disclosure of the study information | 2014/12/12 |
| Last modified on | 2014/12/12 19:01:57 |
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Basic information
Public title
Prospective observational study of Idiopathic pulmonary fibrosis with Non-small-cell lung cancer(LOGIK0603)
Acronym
Prospective observational study of Idiopathic pulmonary fibrosis with Non-small-cell lung cancer(LOGIK0603)
Scientific Title
Prospective observational study of Idiopathic pulmonary fibrosis with Non-small-cell lung cancer(LOGIK0603)
Scientific Title:Acronym
Prospective observational study of Idiopathic pulmonary fibrosis with Non-small-cell lung cancer(LOGIK0603)
Region
| Japan |
Condition
Condition
Idiopathic pulmonary fibrosis
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the frequency of acute exacerbation as the time course of idiopathic pulmonary fibrosis with non-small-cell lung cancer. About the patients treated with paclitaxel and carboplatin combination therapy as an anticancer agent for non-small-cell lung cancer, we observe the frequency of acute exacerbation and the death rate with anticancer drug treatment. Moreover, we observe the effectiveness about the patient having an evaluable lesion and other safety.
Basic objectives2
Others
Basic objectives -Others
To observe prospectively the frequency of acute exacerbation as the time course of idiopathic pulmonary fibrosis with non-small-cell lung cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of acute exacerbation of idiopathic pulmonary fibrosis
Key secondary outcomes
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.
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/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.
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
1) Patient with idiopathic pulmonary fibrosis.
2) Patient with chemotherapy naïve confirmed by histological diagnosis or cytodiagnosis to be non-small cell cancer including the recurrent patient after surgery for primary lesion (except the patient treated with adjuvant chemotherapy including UFT) and excluding the patient after radiation exposure for primary lesion. When palliative radiation therapy (gamma knife, irradiation to a bone metastatic focus) to any place other than the primary lesion is provided, it can be registered if more than 2 weeks after the radiation therapy passes.
3) Patient with clinical stage of IIIB and IV period that radical cure irradiation is impossible.
*The patient impossible of pleural effusion control is excluded. The patients with pleural effusion control can be enrolled after more than 4weeks of pleurodesis by MINO or OK432, and are confirmed that there is no exacerbation of idiopathic pulmonary fibrosis after the drug administration.
*The patient not to hope for an operation eve if it is operable, the patient that cannot but give up radiation therapy because of pulmonary fibrosis eve if it is possible for radical cure irradiation, the enrollment of such patients are possible.
4) Age 20 years or older and younger than 75 years (at the date of informed consent).
5) ECOG performance status (PS) :0-1
6) Patients with sufficient organ function.
7) Patients with survival expectation of more than 12 weeks.
8) Patient with written informed consent.
Key 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.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Ebi |
Organization
Iizuka Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
3-83 Yoshio-machi Iizuka-shi Fukuoka,Japan
TEL
0948-22-3800
nebi1@aih-net.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Ebi |
Organization
Iizuka Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
3-83 Yoshio-machi Iizuka-shi Fukuoka,Japan
TEL
0948-22-3800
Homepage URL
nebi1@aih-net.com
Sponsor or person
Institute
Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
飯塚病院 呼吸器内科 （福岡県）
新別府病院 呼吸器内科 （大分県）
近畿大学 腫瘍内科 （大阪府）
久留米大学 呼吸器内科 （福岡県）
熊本地域医療センター 呼吸器内科 （熊本県）
九州医療センター 呼吸器科 （福岡県）
熊本大学 呼吸器内科 （熊本県）
JCHO九州病院 内科 （福岡県）
福岡東医療センター 呼吸器科 （福岡県）
長崎大学 第二内科 （長崎県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2007 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 22 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 26 | Day |
Date trial data considered complete
| 2012 | Year | 07 | Month | 03 | Day |
Date analysis concluded
| 2012 | Year | 07 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 12 | Day |
Last modified on
| 2014 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018311
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