UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009872 |
|---|---|
| Receipt number | R000011568 |
| Scientific Title | Phase II study of continuation maintenance by use of TS1 after induction chemotherapy of cisplatin and TS1 in patients with Stage IIIB / IV non-small cell lung cancer-Research of efficacy predictive biomarker |
| Date of disclosure of the study information | 2013/01/31 |
| Last modified on | 2019/03/30 15:23:49 |
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Basic information
Public title
Phase II study of continuation maintenance by use of TS1 after induction chemotherapy of cisplatin and TS1 in patients with Stage IIIB / IV non-small cell lung cancer-Research of efficacy predictive biomarker
Acronym
Phase II of cisplatin and TS1 followed by TS1
Scientific Title
Phase II study of continuation maintenance by use of TS1 after induction chemotherapy of cisplatin and TS1 in patients with Stage IIIB / IV non-small cell lung cancer-Research of efficacy predictive biomarker
Scientific Title:Acronym
Phase II of cisplatin and TS1 followed by TS1
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of cisplatin and TS1 followed by TS1 in patients with Stage IIIB / IV non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival from the beginning of maintenance therapy
Key secondary outcomes
Response rate by RECIST, Overall survival, Time to treatment failure,
Adverse events, Quality of life, Efficacy predictive factors (Thymidylate synthase, Dihydoropyrimidine dehydrogenase, others)
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 and TS1 followed by TS1
the other trial of same chemotherapy with bevacizumab at same time
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
Eligibility criteria for Pre-registration
1) Histologically or cytologically proven non-small cell lung cancer
2) Stage IIIB/IV without indication for radical thoracic irradiation or recurrence after surgical treatment
3) Naive treatment of cytotoxic chemotherapy.
Treatments below are acceptable for pre-registaration
a) Palliative Irradiation except primary tumor of lung more than 2 weeks ago
b)First line treatment by epidermal growth factor receptor-tyrosine kinase inhibitors more than 2 weeks ago
c)post-operation adjuvant therapy more than 6 months.
4)Eastern Cooperative Oncology Group performance status of 0-1
5)Age; > or = 20 years and < 75 years
6) Tumor has the evaluable lesion.
7) capable of oral intake
8) Adequate organ function, Adequate organ function within 2 weeks
a) Leukocyte count; > or = 3,000/mm3
b) Neutrophil count; > or = 1,500/mm3
c) Platelet count; > or = 100,000/mm3
d) Hemoglobin concentration; > or = 10.0g/dl
e) Total bilirubin level; < or = 2.0 mg/dl
f) Aspartate aminotransferse and alanine aminotransferase levels; < or = 100 IU/L
g) PaO2; > or = 60 Torr or SpO2; > or = 90% at room air
h) Creatinine clearance; > or = 60mL/min
9) Estimating Survival more than 12 weeks
10)Written informed consent
II)Eligibility criteria for registration
1) More than 2 cycles of induction chemotherapy
2) Response criteria of induction chemotherapy achieved more than and equal to SD.
3) Maintenance start within 6 weeks after start of TS1 of last cycle.
Key exclusion criteria
1) History of allergic reaction for agents of present treatment
2) Severe myelosupperssion, renal dysfunction or hepatic dysfunction
3) Patients received post-operation adjuvant therapy within 6 months.
4) Active concomitant malignancy except carcinoma in situ, intramucosal carcinoma or cancer with more than 5 year disease free
5) Significant comorbid disease such as paresis of intestine, ileus, interstitial pneumonia, lung fibrosis, uncontrolled diabetes mellitus, cardiac failure, renal failure, hepatic failure, active gastrointestinal ulcer, myocardial infarction and angina pectoris within 6 months, other uncontrolled disease
6) Diarrhea more than and equal to grade 2
7) Active infection more than and equal to grade 2
8) Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage
9) Symptomatic brain metastasis but eligible for controlled brain metastases
10) Patients required for continuing steroid therapy
11) Pregnant status or lactation
12) Uncontrolled psychiatric disease
13) Other ineligible status judged by medical oncologist.
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Takeda |
Organization
National Center for Global health and Medicine
Division name
Department of Respiratory Medicine
Zip code
162-865
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL
03-3202-7181
ytakeda@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Takeda |
Organization
National Center for Global health and Medicine
Division name
Department of Respiratory Medicine
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL
03-3202-7181
Homepage URL
ytakeda@hosp.ncgm.go.jp
Sponsor or person
Institute
Department of Respiratory Medicine
National Center for Global health and Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Center for Clinical sciences, National Center for Global health and Medicine
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
Tel
03-3202-7181
rinrijim@hosp.ncgm.go.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
国立国際医療研究センター病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 31 | 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
14
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
Terminated
Date of protocol fixation
| 2012 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will terminate at March 31, 2019 because of forced termination based on the clinical study law in Japan.
Management information
Registered date
| 2013 | Year | 01 | Month | 25 | Day |
Last modified on
| 2019 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011568
