UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001319 |
|---|---|
| Receipt number | R000001606 |
| Scientific Title | A pilot study of adjuvant chemotherapy with cisplatin and irinotecan for High grade pulmonary neuroendocrine carcinona (Large cell neuroendocrine carcinoma and small cell lung cancer) |
| Date of disclosure of the study information | 2008/08/18 |
| Last modified on | 2010/11/19 13:37:37 |
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Basic information
Public title
A pilot study of adjuvant chemotherapy with cisplatin and irinotecan for High grade pulmonary neuroendocrine carcinona (Large cell neuroendocrine carcinoma and small cell lung cancer)
Acronym
A pilot study of adjuvant chemotherapy with cisplatin and irinotecan for High grade pulmonary neuroendocrine carcinona (Large cell neuroendocrine carcinoma and small cell lung cancer)
Scientific Title
A pilot study of adjuvant chemotherapy with cisplatin and irinotecan for High grade pulmonary neuroendocrine carcinona (Large cell neuroendocrine carcinoma and small cell lung cancer)
Scientific Title:Acronym
A pilot study of adjuvant chemotherapy with cisplatin and irinotecan for High grade pulmonary neuroendocrine carcinona (Large cell neuroendocrine carcinoma and small cell lung cancer)
Region
| Japan |
Condition
Condition
High grade pulmonary neuroendocrine carcinona (Large cell neuroendocrine carcinoma and small cell lung cancer)
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the tolerability of irinotecan and cisplatin adjuvant chemotherapy for High grade pulmonary neuroendocrine carcinona (Large cell neuroendocrine carcinoma and small cell lung cancer)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
the rate of completion of chemotherapy
Key secondary outcomes
3-years overall survival
3-years relapse free survival
Incidence of an adverse event
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 60mg/m2 on day 1
irinotecan 60mg/m2 on days 1,8 and 15
start within 4-10 weeks after surgery
q4weeks,4 courses
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)be able to start chemotherapy within 4-10 weeks after surgery
2) histologically confirmed large cell neuroendocrine carcinoma and small cell lung cancer, completely resected, pathological stage IA, IB, IIA, IIB and IIIA
3) age 20-70 years old
4) Performance status (ECOG performance status score)0-1
5) no prior chemotherapy with platinum-based or irinotecan regimen
6) adequate organ function
. WBC>=4,000 /mm3
. Hemoglobin>=9.5g/dL
. Platelet count>=100,000/mm3
. Total serum bilirubin<=1.5mg/dL
. GOT, GPT<100 IU/L
. Serum creatinine<=1.5mg/dL
. PaO2>=70mmHg
7) without UGT1A128(TA)7/7homo, UGT1A16(211G>A)+/+homo, UGT1A128(TA)6/7hetero nor UGT1A16(211G>A)-/+hetero
8) written informed consent
Key exclusion criteria
1) prior radiotherapy
2) active concomitant malignancy
3) with uncontrolled pleural/pericardial effusion
4) with interstitial pneumonia or pulmonary fibrosis as determined by chest x-ray
5) watery diarrhea
6) intestinal obstruction or paralysis
7) symptomatic brain metastasis
8) with serious complications
.cardiac failure, stenocardia, and myocardial infarction within the previous 3 months
.uncontrolled diabetes mellitus and hypertension
.uncontrolled infection
9) pregnant or lactating women
10) psychological disease deemed unacceptable for inclusion to the study
11) with severe drug allergy
12) doctor's decision not to be registered to this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kanji Nagai |
Organization
National cancer center east
Division name
Thoracic Surgery Division
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa-shi, Chiba 277-8577, Japan
TEL
04-7133-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaoru Kubota |
Organization
National cancer center east
Division name
Thoracic Oncology Division
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa-shi, Chiba 277-8577, Japan
TEL
04-7133-1111
Homepage URL
Sponsor or person
Institute
Department Thoracic Oncology, National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Department Thoracic Oncology, National Cancer Center Hospital East
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2008 | Year | 08 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 18 | Day |
Last modified on
| 2010 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001606
