UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000214 |
|---|---|
| Receipt number | 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 19:42:23 |
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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
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
kkiura@md.okayam-u.ac.jp
Sponsor or person
Institute
Japan SCLC/PBSCT Study Group
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000272
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