UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016191 |
|---|---|
| Receipt number | R000018790 |
| Scientific Title | Feasibility study of adjuvant chemotherapy with S-1 plus cisplatin for stage II-IIIA non-small cell lung cancer |
| Date of disclosure of the study information | 2015/01/12 |
| Last modified on | 2021/05/21 10:02:25 |
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Basic information
Public title
Feasibility study of adjuvant chemotherapy with S-1 plus cisplatin
for stage II-IIIA non-small cell lung cancer
Acronym
S-1 + CDDP for adjuvant chemotherapy in NSCLC
Scientific Title
Feasibility study of adjuvant chemotherapy with S-1 plus cisplatin
for stage II-IIIA non-small cell lung cancer
Scientific Title:Acronym
S-1 + CDDP for adjuvant chemotherapy in NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of S-1 plus cisplatin as adjuvant chemotherapy for stage II-IIIA non-small cell lung cancer after curative resection.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Completion rate of four cycles of S-1 plus cisplatin.
Key secondary outcomes
Overall survival, time to treatment failure, relapse-free survival, toxicity, dose delivery, recurrent status
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
Four cycles of S-1 plus cisplatin as adjuvant 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) Pathologically diagnosed non-small cell lung cancer
2) pStage II-IIIA
3) Completely resected
4) Surgically treated patients
5) ND2a-2 or more
6) No prior therapy
7) ECOG Perfomance Status 0-1
8) Age 20-75 year-old
9) Able to oral intake
10) Adequate organ function
11) PaO2 >= 65mmHg or SpO2 >= 92%
12) Able to start within 8 weeks after the surgery
13) Written informed concent
Key exclusion criteria
1) Drug allergy
2) Administering Flucytosine
3) Interstitial pneumonia
4) Serious medical complications
5) Diarrhea
6) Active double malignancies
7) Mental status
8) Pregnancy, breastfeeding or suspected of being pregnant
9) Pneumonectomy
10) Others judged by attending physician
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Iyoda |
Organization
Toho University Omori Medical Center
Division name
Chest Surgery
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
TEL
03-3752-4151
aiyoda@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Sano |
Organization
Toho University Omori Medical Center
Division name
Chest Surgery
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
TEL
03-3752-4151
Homepage URL
sanoa-tky@umin.ac.jp
Sponsor or person
Institute
Division of Chest Surgery, Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Division of Chest Surgery, Toho University Omori Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Respirology and General Thoracic Surgery, NTT Medical Center Tokyo
Department of Thoracic and Cardiovascular Surgery, Self-Defense Forces Central Hospital
Division of Thoracic and Cardiovascular Surgery, Showa University School of Medicine
Respiratory Disease Center, Showa University Northern Yokohama Hospital
Division of Chest Surgery and Respiratory Medicine, Toho University Omori Medical Center
Division of Surgery, Toho University Ohashi Medical Center
Division of Surgery, Toho University Sakura Medical Center
Department of Respiratory Medicine, Toranomon Hospital
Department of Thoracic Surgery, Mitsui Memorial Hospital
Division of General Thoracic Surgery, Yokosuka Kyosai Hospital
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
the Ethics Committee of Toho University Omori Medical Center
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
Tel
03-3762-4151
somu.omori@jim.toho-u.ac.jp
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
| 2015 | Year | 01 | Month | 12 | 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
| 2013 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 02 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 12 | Day |
Last modified on
| 2021 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018790
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