UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035812 |
|---|---|
| Receipt number | R000040750 |
| Scientific Title | Phase II study of S-1/paclitaxel combination therapy in patients with previously treated non-small cell lung cancer |
| Date of disclosure of the study information | 2019/02/08 |
| Last modified on | 2019/02/08 14:40:22 |
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Basic information
Public title
Phase II study of S-1/paclitaxel combination therapy in patients with previously treated non-small cell lung cancer
Acronym
Phase II study of S-1/paclitaxel combination therapy in patients with previously treated non-small cell lung cancer
Scientific Title
Phase II study of S-1/paclitaxel combination therapy in patients with previously treated non-small cell lung cancer
Scientific Title:Acronym
Phase II study of S-1/paclitaxel combination therapy in patients with previously treated non-small cell lung cancer
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This trial evaluated the efficacy and toxicity of S-1/paclitaxel combination therapy in patients with previously treated non-small cell lung cancer (NSCLC).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall response rate
Key secondary outcomes
Progression-free survival
Overall survival
safety
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
S1 is administered orally twice daily for 14 days a day, according to the body surface area, followed by 7 days off. PTX 80 mg / m 2 is administered on Day 1, 8 by drip infusion. One cycle is 21 days.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) A case in which definitive diagnosis of non-small cell lung cancer was obtained by histology or cytology
2) Cases with measurable lesions
3) Patients with a history of chemotherapy treatment containing 1 platinum regimen over 1 regimen (treatment history of surgical therapy and radiotherapy is not limited)
4) Cases with 4 weeks or more have passed since the end of previous chemotherapy
5) Case of over 20 years old
6) Case of Performance Status 0-1 of ECOG
7) Cases with sufficient bone marrow function and organ function
8) Cases in which survival for more than 2 months can be expected
9) Cases with oral administration
10) Case informed consent obtained document from patient himself
Key exclusion criteria
1: Cases with serious complications
Interstitial pneumonia
Serious heart disease
diabetes which is difficult to control
Serious infectious diseases
2: Cases with other active organs and overlapping cancers
3: Patients with a history of severe hypersensitivity
4: Case in which flucytosine is being administered
5) Cases with a history of alcohol hypersensitivity
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Iwasaki |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Pulmonary Medicine
Zip code
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL
075-251-5513
c1981311@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Chihara |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Pulmonary Medicine
Zip code
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL
075-251-5513
Homepage URL
c1981311@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
| 2019 | Year | 02 | Month | 08 | 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
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 12 | 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
| 2019 | Year | 02 | Month | 08 | Day |
Last modified on
| 2019 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040750
