UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009993 |
|---|---|
| Receipt number | R000011703 |
| Scientific Title | Phase I study on the feasibility of Nedaplatin plus S-1 combination therapy for squamous cell lung cancer. |
| Date of disclosure of the study information | 2013/02/18 |
| Last modified on | 2018/03/29 07:49:54 |
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Basic information
Public title
Phase I study on the feasibility of Nedaplatin plus S-1 combination therapy for squamous cell lung cancer.
Acronym
Nedaplatin plus S-1 combination therapy for squamous cell lung cancer
Scientific Title
Phase I study on the feasibility of Nedaplatin plus S-1 combination therapy for squamous cell lung cancer.
Scientific Title:Acronym
Nedaplatin plus S-1 combination therapy for squamous cell lung cancer
Region
| Japan |
Condition
Condition
Squamous cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The feasibility of Nedaplatin plus S-1 combination therapy for squamous cell lung cancer and dose of Nedaplatin are tested.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Determination of recommended dose of nedaplatin in the case of combination with S-1
Key secondary outcomes
Safety, Drug adherence rate, response rate
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
Nedaplatin plus S-1
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. Patient who had squamous lung cancer, neither surgery nor radiation indication, accompanied by anti-cancer chemotherapy
2. Informed consent is obtained
3.Patient who is judged as an appropriate case by the doctor in charge
4. PS0-1
5. No history of cardiac failure, renal failure, or liver damage.
Key exclusion criteria
1. Patient who have severe infection
2. Pregnant or lactating women.
3. Multiple cancer
4. A known history of allergy
5. A known history of GI bleeding
6. Patient who have interstitial pneumonia
7. Patient who have severe diabetes mellitus, liver cirrhosis, renal dysfunction, angina pectoris, arrhythmia, or myocardiac infarction before 3 months
8. Patient who have therapeutic need of pleural effusion, pericardiac effusion, or SVC syndrome
9. Patient who have obscure symptoms of brain metastasis.
10. Patient who have obscure symptoms of peripheral nerve dysfunction
11. Patient who take flucytosin.of brain
12. Patient who have severe
13.patient who is judged as an inappropriate case by the doctor in charge
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Fujita |
Organization
Fukuoka University Hospital
Division name
Respiratory Medicine
Zip code
Address
7-45-1 Nanakuma, Jonanku, Fukuoka
TEL
092-801-1011
mfujita@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Fujita |
Organization
Fukuoka University Hospital
Division name
Respiratory Medicine
Zip code
Address
7-45-1 Nanakuma, Jonanku, Fukuoka
TEL
092-801-1011
Homepage URL
mfujita@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, Fukuoka 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
福岡大学病院（福岡県）
福岡大学筑紫病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | 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
Because of shortage of case accumulation, the study was terminated.
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
Terminated
Date of protocol fixation
| 2013 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 07 | Day |
Last modified on
| 2018 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011703
