UMIN-CTR Clinical Trial

Basic information
Public title	A Phase II Study of Cisplatin, Etoposide and Concurrent Thoracic Irradiation Followed by Irinotecan and Cisplatin in Patients with Limited Small-Cell Lung Cancer
Acronym	A Phase II Study of Cisplatin, Etoposide and Concurrent Thoracic Irradiation Followed by Irinotecan and Cisplatin in Patients with Limited Small-Cell Lung Cancer
Scientific Title	A Phase II Study of Cisplatin, Etoposide and Concurrent Thoracic Irradiation Followed by Irinotecan and Cisplatin in Patients with Limited Small-Cell Lung Cancer
Scientific Title:Acronym	A Phase II Study of Cisplatin, Etoposide and Concurrent Thoracic Irradiation Followed by Irinotecan and Cisplatin in Patients with Limited Small-Cell Lung Cancer
Region	Japan

Condition
Condition	LD-SCLC
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and the toxicity of cisplatin and etoposide with concurrent twice-daily thoracic irradiation followed by a consolidation of cisplatin and irinotecan in patients with limited-stage small-cell lung cancer in a phase II study.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Two-year survival rate
Key secondary outcomes

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	Cisplatin and etoposide with concurrent twice-daily thoracic irradiation followed by 3 cycles of cisplatin and 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	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Histologically or cytologically confirmed limited-stage SCLC 2. No prior chemotherapy or radiotherapy 3. Measurable disease 4. ECOG performance status of 0-2 5. Age between 20 and 70 years 6. Life expectancy ≥ 3 months 7. Adequate organ funtion: Leukocyte count from 4,000 to 12,000/mm3; hemoglobin concentration ≥9.5 g/dl; platelet count ≥100,000/mm3; aspartate aminotransferase and alanine aminotransferase ≤2 times of the upper limit of normal value; serum bilirubin ≤1.5 mg/d; serum creatinine ≤the upper limit of normal value; 24-hour creatinine clearance ≥60 ml/min; and PaO2 ≥70 torr 8. Signed informed consent
Key exclusion criteria	1. Clinically apparent interstitial pneumonitis or pulmonary fibrosis 2. Emphysema, chronic bronchitis or bronchial asthma which precludes thoracic radiotherapy 3. Malignant pleural effusion or malignant pericardial effusion 4. Active concomitant or a recent (<3 years) history of any malignancy 5. Uncontrolled hypertension, unstable angina pectoris, myocardial infarction <3 months before enrollment or congestive heart failure 6. Uncontrolled diabetes mellitus 7. Uncontrolled severe active infection 8. Intestinal paralysis or obstruction 9. Pregnancy or lactation
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroshi Saito, M.D.
Organization	Aichi Cancer Center Aichi Hospital
Division name	Department of Respiratory Medicine
Zip code
Address	18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, Japan.
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Shinichiro Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
Zip code
Address
TEL	06-6633-7400
Homepage URL
Email

Sponsor
Institute	West Japan Oncology 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 02 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://www.ncbi.nlm.nih.gov/pubmed?term=17114657
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	2001 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date	2001 Year 01 Month 01 Day
Last follow-up date	2005 Year 01 Month 01 Day
Date of closure to data entry	2005 Year 01 Month 01 Day
Date trial data considered complete	2005 Year 05 Month 01 Day
Date analysis concluded	2005 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 09 Month 02 Day
Last modified on	2015 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000159

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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