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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000214
Receipt No. R000000272
Scientific Title A Randomized Clinical Trial of High-Dose Chemotherapy with Autologous Peripheral Blood Stem Cell Transplantation in Limited-Disease Small-Cell Lung Cancer.
Date of disclosure of the study information 2005/09/13
Last modified on 2016/09/15

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Basic information
Public title A Randomized Clinical Trial of High-Dose Chemotherapy with Autologous Peripheral Blood Stem Cell Transplantation in Limited-Disease Small-Cell Lung Cancer.
Acronym A Randomized Clinical Trial of High-Dose Chemotherapy with Autologous Peripheral Blood Stem Cell Transplantation in Limited-Disease Small-Cell Lung Cancer.
Scientific Title A Randomized Clinical Trial of High-Dose Chemotherapy with Autologous Peripheral Blood Stem Cell Transplantation in Limited-Disease Small-Cell Lung Cancer.
Scientific Title:Acronym A Randomized Clinical Trial of High-Dose Chemotherapy with Autologous Peripheral Blood Stem Cell Transplantation in Limited-Disease Small-Cell Lung Cancer.
Region
Japan

Condition
Condition Small-cell lung cacer, limited disease
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We conducted a phase II study of high-dose chemotherapy consisting ofifosfamide, carboplatin, and etoposide facilitated by autologous peripheral blood stem cell transplantation for the treatment of limited-disease small-cell lung cancer. CR rate after high dose chemotherapy was 61%. Median survival time was 36.4 months. Overall and event-free survival rate at 3 years from the beginning of induction therapy were 55.6%+/-11.7% and 50%+/-11.7%, respectively. These results indicate that high dose chemotherapy with autologous peripheral blood stem cell transplantation can be used as a cure-oriented treatment modality for limited-disease small-cell lung cancer. Based on these results, we constructed a prospective randomized trial to demonstrate efficacy of high-dose chemotherapy with autologous peripheral blood stem cell transplantation in limited-disease small-cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes 5-year disease free survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Cisplatin + etoposide with conccrent accelerated hyperfractionated thoracic radiation therapy followed by
high-dose chemotherapy (ifosfamide/carboplatin/etoposide) with autologous peripheral blood stem cell transplantation
Interventions/Control_2 Cisplatin + etoposide with conccrent accelerated hyperfractionated thoracic radiation therapy
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

Not applicable
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1. Histologically or cytologically documented SCLC
2. No prior therapy
3. 65 years old or less
4. Performance status (ECOG) of 0 - 2
5. Normal hematologic function:
WBC>=4000/microml, PLT>=100,000/microml
6. Normal hepatic function:
T-Bil=<1.5 mg/dl, AST, ALT=<2.5 x normal
7. Normal renal function:
Creatinine=<1.5 mg/ml, Ccr=<60 ml/min
8. Normal pulmonary function:
PaO2=<60 Torr, %DLco>=60%
9. Normal cardiac function: Ejection fraction=>60%
10. Written informed consent

Eligibility Criteria for High-Dose Chemotherapy
1. Responders to the induction chemotherapy: CR or PR
2. Performance status (ECOG) of 0 - 1
3. Normal hematologic, hepatic, renal, pulmonary and cardiac functions
4. PBSCs CD34 positive cells=>1x10^6/kg
Key exclusion criteria Patients who had tumors involvement in the bone marrow or brain, active double cancers or serious underlying disease (interstitial pneumonia, serious cardiac diseases, uncontrolled diabetes mellitus, serious infection, carrier of HBV, HCV,or HIV) are excluded.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mine Harada, M.D, Ph.D. Professor & Chairman
Organization Kyushu University
Division name Faculty of Medical Sience
Zip code
Address 3-1-1Maidashi, Higashiku, Fukuoka
TEL 092-642-1151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuyuki Kiura, M.D. Ph.D.
Organization Okayama University Graduate School of Medicine, Dentistry, and Phamaceutical Science
Division name Department of Hematology, Oncology, and Respiratory Midicine
Zip code
Address 2-5-1 Shikata-cho, Okayama700-8558
TEL 086-235-7225
Homepage URL
Email kkiura@md.okayam-u.ac.jp

Sponsor
Institute Japan SCLC/PBSCT 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
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

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Terminated
Date of protocol fixation
2001 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2001 Year 07 Month 01 Day
Last follow-up date
2006 Year 07 Month 01 Day
Date of closure to data entry
2007 Year 07 Month 01 Day
Date trial data considered complete
2007 Year 07 Month 01 Day
Date analysis concluded
2010 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 13 Day
Last modified on
2016 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000272

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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