UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Randomized Clinical Trial of High-Dose Chemotherapy with Autologous Peripheral Blood Stem Cell Transplantation in Limited-Disease Small-Cell Lung Cancer.
Title of the study (Brief title)	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	Mine Harada, M.D, Ph.D. Professor & Chairman
Organization	Kyushu University
Division name	Faculty of Medical Sience
Address	3-1-1Maidashi, Higashiku, Fukuoka
TEL	092-642-1151
Email

Public contact
Name of contact person	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
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2001 Year 07 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000000272