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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000128 |
Receipt No. | R000000191 |
Scientific Title | A combination phase I/II study of topotecan with carboplatin for relapsed small cell lung cancer |
Date of disclosure of the study information | 2005/09/07 |
Last modified on | 2015/08/31 |
Basic information | ||
Public title | A combination phase I/II study of topotecan with carboplatin for relapsed small cell lung cancer | |
Acronym | A combination phase I/II study of topotecan with carboplatin for relapsed small cell lung cancer | |
Scientific Title | A combination phase I/II study of topotecan with carboplatin for relapsed small cell lung cancer | |
Scientific Title:Acronym | A combination phase I/II study of topotecan with carboplatin for relapsed small cell lung cancer | |
Region |
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Condition | ||
Condition | relapsed small cell lung cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To establish the toxicities and maximum tolerated dose (MTD) of topotecan with carboplatin, and to determine the recommended dose (RD) for relapsed small cell lung cancer (SCLC). |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase I,II |
Assessment | |
Primary outcomes | to establish MTD and to determine the RD. |
Key secondary outcomes |
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 |
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Interventions/Control_1 | The treatment schedule included carboplatin, diluted with 500 ml of normal saline, given intravenously over 90 minutes on day 5, and topotecan with 100 ml of normal saline, given intravenously over 30 minutes before the administration of carboplatin infusion on days 1 to 5, every 3 weeks | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
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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 | Patients with histologic or cytologic confirmation of SCLC who received one prior chemotherapy regimen were eligible.
The eligibility criteria were as follows; (1) measurable lesions; (2) age ≥ 20, <75; (3) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1; (4) adequate organ function |
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Key exclusion criteria | The exclusion criteria consisted of pulmonary fibrosis or interstitial pneumonitis with symptoms or apparent abnormalities on chest X-ray, massive pleural effusion or ascites, acute inflammation, symptomatic brain metastases, active concurrent malignancies, severe drug allergies, severe heart disease, cerebrovascular disease, uncontrollable diabetes mellitus, severe infection. | |||
Target sample size | 38 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hyogo Medical Center for Adults | ||||||
Division name | Department of Medical Oncology | ||||||
Zip code | |||||||
Address | 13-70, Kitaoji-cho, Akashi City, Hyogo, Japan, 673-8558 | ||||||
TEL | 078-929-1151 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Hyogo Medical Center for Adults | ||||||
Division name | Department of Medical Oncology | ||||||
Zip code | |||||||
Address | Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN | ||||||
TEL | 06-6633-7400 | ||||||
Homepage URL | |||||||
datacenter@wjog.jp |
Sponsor | |
Institute | West Japan Oncology Group |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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://www.ncbi.nlm.nih.gov/pubmed?term=19325498 |
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 | Completed | ||||||
Date of protocol fixation |
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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 | |
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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=R000000191 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |