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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003208
Receipt No. R000003889
Scientific Title A feasibility study of carboplatin and irinotecan regimen in elderly patients with extensive disease small cell lung cancer.
Date of disclosure of the study information 2010/02/22
Last modified on 2014/08/18

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Basic information
Public title A feasibility study of carboplatin and irinotecan regimen in elderly patients with extensive disease small cell lung cancer.
Acronym Caroboplatin/iritotecan regimen in elderly patients with ED-SCLC
Scientific Title A feasibility study of carboplatin and irinotecan regimen in elderly patients with extensive disease small cell lung cancer.
Scientific Title:Acronym Caroboplatin/iritotecan regimen in elderly patients with ED-SCLC
Region
Japan

Condition
Condition elderly patients with extensive disease small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To find whether or not a carboplatin/irinotecan regimen can be recognized as an experimental arm of future phase III trial in elderly patients with extensive disease small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes feasibility
Key secondary outcomes toxicity, response rate, survival

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
irinotecan
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Eligibility criteria included patients with histologically or cytologically confirmed SCLC who were >/=70 years in age and had an Eastern Cooperative Oncology Group performance status (PS) of 0 to 2. Additional criteria consisted of extensive disease (ED), chemotherapy-naive, adequate organ functions [leukocyte count >/=4,000/mm3, platelet count >/=100,000/mm3, hemoglobin level >/=9.0 g/dl, AST/ALT </=2 x upper limit of normal range, total bilirubin </=1.5 mg/dl, creatinine</=1.5 mg/dl, creatinine clearance (Ccr) >/=50 ml/min, and PaO2 >/=60 mmHg, and written informed consent
Key exclusion criteria Exclusion criteria included symptomatic pericardial or pleural effusion requiring drainage, active concomitant malignancy, senile dementia, brain metastases requiring radiotherapy, superior vena cava (SVC) syndrome requiring radiotherapy, active infection, interstitial pneumonia, diarrhea, ileus, and serious medical or psychiatric illness.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Okamoto
Organization Yokohama Municipal Citizen's Hospital
Division name Department of Respiratory Medicine
Zip code
Address 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa 240-8555, JAPAN
TEL 045-331-1961
Email hi01-okamoto@city.yokohama.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoya Hida, Yuuki Misumi
Organization Yokohama Municipal Citizen's Hospital
Division name Department of Respiratory Medicine
Zip code
Address 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa 240-8555, JAPAN
TEL 045-331-1961
Homepage URL
Email na00-hida@city.yokohama.jp

Sponsor
Institute Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization none

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 横浜市立市民病院、国立がんセンター中央病院、国立がんセンター東病院、岐阜市民病院、癌研有明病院、静岡がんセンター

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://jjco.oxfordjournals.org/content/44/2/116.long
Number of participants that the trial has enrolled
Results
Abstract
OBJECTIVE: 
 The role of platinum agents plus irinotecan has been unclear for elderly patients with extensive disease small-cell lung cancer. We conducted a feasibility study to evaluate the safety and efficacy of carboplatin plus irinotecan in preparation for a planned Phase III study.
METHODS: 
 Based on another Phase I study, carboplatin area under the curve of four Day 1 plus irinotecan 50 mg/m(2) Days 1 and 8 every 3 weeks for four courses was administered. Patients aged &#8805;70 years with a performance status of 0-2 were eligible. The primary endpoint was feasibility, defined as the percentage of patients who have received three or more courses of chemotherapy. If the feasibility was &#8805;60% in the first 10 patients, this endpoint would be considered to be met.
RESULTS: 
 Eleven patients were registered. The median age was 77 years, and nine patients had a performance status of 1. Ten patients completed four courses of treatment, and neither dose omission nor modification was required. The feasibility was 91% (10/11) and the relative dose intensity was 76.9%. Because neutropenia was frequently prolonged, the next course was delayed in 53% of all courses. Other toxicities were generally mild, and the only Grade 4 toxicity was hyponatremia. The overall response rate was 90% (9/10), and the progression-free survival and the overall survival were 5.1 and 10.9 months, respectively.
CONCLUSIONS: 
 This regimen appears to be feasible and effective. Based on these results, a Phase II/III trial comparing carboplatin plus etoposide with carboplatin plus irinotecan for elderly patients with extensive disease small-cell lung cancer is being planned by the Japan Clinical Oncology Group.
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
2010 Year 02 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2013 Year 04 Month 01 Day
Date of closure to data entry
2013 Year 04 Month 01 Day
Date trial data considered complete
2013 Year 04 Month 01 Day
Date analysis concluded
2013 Year 04 Month 01 Day

Other
Other related information A feasibility study of carboplatin plus irinotecan treatment for elderly patients with extensive disease small-cell lung cancer. Misumi Y, Nishio M, Takahashi T, Ohyanagi F, Horiike A, Murakami H, Kenmotsu H, Yamamoto N, Ishii M, Shimokawa T, Hida N, Okamoto H. Jpn J Clin Oncol. 2014 Feb;44(2):116-21. doi: 10.1093/jjco/hyt195. Epub 2013 Dec 13.

Management information
Registered date
2010 Year 02 Month 18 Day
Last modified on
2014 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003889

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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