UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003993 |
|---|---|
| Receipt number | R000004702 |
| Scientific Title | Feasibility study of carboplatin plus TS-1 combination chemotherapy for completely resected non-small cell lung cancer (ALCSG-1001) |
| Date of disclosure of the study information | 2010/08/04 |
| Last modified on | 2010/08/03 17:00:42 |
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Basic information
Public title
Feasibility study of carboplatin plus TS-1 combination chemotherapy for completely resected non-small cell lung cancer (ALCSG-1001)
Acronym
Feasibility study of carboplatin plus TS-1 combination chemotherapy for completely resected non-small cell lung cancer (ALCSG-1001)
Scientific Title
Feasibility study of carboplatin plus TS-1 combination chemotherapy for completely resected non-small cell lung cancer (ALCSG-1001)
Scientific Title:Acronym
Feasibility study of carboplatin plus TS-1 combination chemotherapy for completely resected non-small cell lung cancer (ALCSG-1001)
Region
| Japan |
Condition
Condition
completely resected non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study the feasibility of carboplatin plus TS-1 combination chemotherapy as adjuvant therapy in patients with completely resected non-small cell lung cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of treatment accomplishment
Key secondary outcomes
Safety, overall survival, relapse-free survival
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
carboplatin plus TS-1 combination chemotherapy
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. Pathological stage II/IIIA non-small cell lung cancer.
2. Completely resected non-small cell lung cancer.
3. No prior treatment.
4. Aged 20 to 74 years old.
5. Performance status of 0 or 1.
6. Sufficient organ functions.
7. Written informed consent.
Key exclusion criteria
1. Patients unable to get treatment of CBDCA or TS-1.
2. Sever allergy.
3. Interstitial pneumonia.
4. Active concomitant neoplasia.
5. uncontrolled heart diseases.
6. Pregnant, lactating women.
7. Sever complications.
8. Inappropriate patients judged by physicians.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Ohsaki |
Organization
Asahikawa Medical University Hospital
Division name
Respiratory Center
Zip code
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa-shi, Hokkaido, 078-8510 Japan
TEL
+81-166-69-3290
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Ohsaki |
Organization
Asahikawa Medical University Hospital
Division name
Respiratory Center
Zip code
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa-shi, Hokkaido, 078-8510 Japan
TEL
+81-166-69-3290
Homepage URL
yohsaki@asahikawa-med.ac.jp
Sponsor or person
Institute
Respiratory Center, Asahikawa Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Respiratory Center, Asahikawa Medical University Hospital
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
旭川医科大学病院（北海道）Asahikawa Medical College, Hokkaido.
旭川厚生病院（北海道）Asahikawa-Kosei general Hospital, Hokkaido.
独立行政法人国立病院機構帯広病院（北海道）National Hospital Organization Obihiro National Hospital, Hokkaido.
独立行政法人国立病院機構道北病院（北海道）National Hospital Organization Dohoku National Hospital, Hokkaido.
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 04 | Day |
Last modified on
| 2010 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004702
