UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007352 |
|---|---|
| Receipt number | R000008663 |
| Scientific Title | Phase I/II trial of carboplatin plus CPT-11 chemotherapy with accelerated hyperfractionated radiotherapy for elderly patients with limited stage small cell lung cancer (TORG0604). |
| Date of disclosure of the study information | 2012/02/23 |
| Last modified on | 2015/09/26 09:26:19 |
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Basic information
Public title
Phase I/II trial of carboplatin plus CPT-11 chemotherapy with accelerated hyperfractionated radiotherapy for elderly patients with limited stage small cell lung cancer (TORG0604).
Acronym
Phase I/II trial of carboplatin plus CPT-11 chemotherapy with accelerated hyperfractionated radiotherapy for elderly patients with limited stage small cell lung cancer (TORG0604).
Scientific Title
Phase I/II trial of carboplatin plus CPT-11 chemotherapy with accelerated hyperfractionated radiotherapy for elderly patients with limited stage small cell lung cancer (TORG0604).
Scientific Title:Acronym
Phase I/II trial of carboplatin plus CPT-11 chemotherapy with accelerated hyperfractionated radiotherapy for elderly patients with limited stage small cell lung cancer (TORG0604).
Region
| Japan |
Condition
Condition
limited stage small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of carboplatin plus CPT-11 chemotherapy with accelerated hyperfractionated radiotherapy for elderly patients with limited stage small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I: recommended dose
Phase II:toxicity profiles, response rate, feasibility
Key secondary outcomes
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
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
carboplatin plus CPT-11 chemotherapy with accelerated hyperfractionated chestradiotherapy
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
1) histopathologically or cytologically confirmed small cell lung cancer
2) 70 years old or more
3) limited stage small cell lung cancer
4) no prior radiotherapy or chemotherapy for the small cell lung cancer
5) Eastern Cooperative Oncology Group Performance Status:0-2
6) measurable disease
7) no other active malignancy
8) adequate organ functions: WBC> 3000/mm3, absolute neutrophil count> 1500/mm3, platelet count> 100000/mm3, hemoglobin> 9g/dL, AST< 2.5*the upper limit of normal(ULN), ALT< 2.5*ULN, bilirubin> 2.0mg/dL, serum creatinine< 1.5mg/dL, creatinine clearance> 40mL/min, PaO2> 70Torr
9) appropriate informed consent form has confirmed before registration
Key exclusion criteria
1) other active malignancy
2) active infection
3) obviously proven interstitial lund disease by x-ray
4) myocardiac infarction within six monthes before registration
5) uncontrollable heart diseases or hepatic diseeases or diabates or hemorrhage
6) severe mental disorder
7) diarrhea or watery stool
8) massive pleural effusion (more than one centimeter thickness of chest CT scan)
9) ileus
Target sample size
41
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Okamoto |
Organization
Yokohama Municipal Citizens' Hospital
Division name
Department of respilatory medicine and clinical oncology
Zip code
Address
56 Okazawa-cho, Hodogaya Ward, Yokohama, Kanagawa prefecture, Japan
TEL
045-331-1961
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Misumi |
Organization
Yokohama Municipal Citizens' Hospital
Division name
Department of respilatory medicine
Zip code
Address
TEL
045-331-1961
Homepage URL
Sponsor or person
Institute
Thoracic Oncology Research Group (TORG)
Institute
Department
Personal name
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
| 2012 | Year | 02 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Completed
Date of protocol fixation
| 2006 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 21 | Day |
Last modified on
| 2015 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008663
