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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000131 |
Receipt No. | R000000193 |
Scientific Title | Phase II study of irinotecan and amrubicin for relapsed non-small-cell lung cancer |
Date of disclosure of the study information | 2005/09/12 |
Last modified on | 2012/03/08 |
Basic information | ||
Public title | Phase II study of irinotecan and amrubicin for relapsed non-small-cell lung cancer | |
Acronym | Irinotecan and amrubicin for relapsed non-small-cell lung cance | |
Scientific Title | Phase II study of irinotecan and amrubicin for relapsed non-small-cell lung cancer | |
Scientific Title:Acronym | Irinotecan and amrubicin for relapsed non-small-cell lung cance | |
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Condition | |||
Condition | Relapsed non-small-cell lung cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate (i) efficacy and (ii) safety of the combination chemotherapy. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Explanatory |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Response rate |
Key secondary outcomes | Adverse events, overall survival, progression-free survival |
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 |
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Interventions/Control_1 | Combination chemotherapy of irinotecan and amrubicin | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Histologically and/or cytologically proven NSCLC
No prior surgery, chemotherapy, or radiotherapy Age ≤ 75 and ≥20 ECOG performance status 0 or 1 Measurable disease adequate bone marrow, lung, hepatic, and renal function No prior therapy within four weeks Written informed consent |
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Key exclusion criteria | Active concomitant malignancy
Active Interstitial pneumonia Massive effusions Unstable angina, recent myocardial infarction Uncontrolled diabetes Severe active infection Other severe complications Pregnant or lactating women Inappropriate condition for this study judged by physicians. |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Okayama University Hospital | ||||||
Division name | Hematology, Oncology, Respiratory Medicine | ||||||
Zip code | |||||||
Address | 2-5-1 Shikata-cho, Okayama 700-8558 | ||||||
TEL | 086-235-7227 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Okayama Lung Cancer Study Group Coordinating Office | ||||||
Division name | Department of Respiratory Medicine, Okayama University Hospital | ||||||
Zip code | |||||||
Address | 2-5-1 Shikata-cho, Okayama 700-8558 | ||||||
TEL | 086-235-7227 | ||||||
Homepage URL | |||||||
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 | |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | http://informahealthcare.com/doi/abs/10.3109/0284186X.2011.648342 |
Number of participants that the trial has enrolled | |
Results | Combination chemotherapy with irinotecan and amrubicin is effective in patients with NSCLC but showed moderate toxicities in second- or third-line settings. |
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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000193 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |