UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000109 |
|---|---|
| Receipt number | R000000159 |
| 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 |
| Date of disclosure of the study information | 2005/09/02 |
| Last modified on | 2015/08/31 15:39:21 |
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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
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
Sponsor or person
Institute
West Japan Oncology 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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000159
