UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004677 |
|---|---|
| Receipt number | R000005277 |
| Scientific Title | Phase II study of S-1 plus Bevacizumab combination chemotherapy for patients with non-small-cell lung cancer. |
| Date of disclosure of the study information | 2011/01/01 |
| Last modified on | 2017/12/12 09:12:56 |
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Basic information
Public title
Phase II study of S-1 plus Bevacizumab combination chemotherapy for patients with non-small-cell lung cancer.
Acronym
S-1 plus Bevacizumab combination chemotherapy for patients with non-small-cell lung cancer.
Scientific Title
Phase II study of S-1 plus Bevacizumab combination chemotherapy for patients with non-small-cell lung cancer.
Scientific Title:Acronym
S-1 plus Bevacizumab combination chemotherapy for patients with non-small-cell lung cancer.
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, S-1 is decided as a combination drug with BEV because it's believed that S-1 become more and more important.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
safety and efficacy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are 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
Bevacizumab (Chugai Pharmaceutical Co. Ltd.,: Avastin)
S-1 (Taiho pharmaceutical Co. Ltd., TS-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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with cytological or histological diagnosis of NSCLC except squamous cell carcinoma.
Patients who have postoperative recurrence, refractory to one chemotherapy regimen.
Preoperative or postoperative adjuvant chemotherapy is not considered as one regimen.
Patience with Measurable lesion based on RECIST ver1.1.
A lesion within a radiation site is excluded from a measurable lesion.
Pleural effusion after pleurodesis is not considered as non-target lesion.
Patients who have 4 weeks or more after the prior chemotherapy.
If the patient underwent therapy, there should be the following interval between the therapy and the registration.
Radiotherapy other than thoracic radiation one week.
Radiotherapy including pulmonary field 3 months.
Surgery, except CV-port reservation 4 weeks
Thoracic drainage two weeks
Open biopsy, treatment of injury two weeks
Aspiration biopsy, CV-port reservation one week
Age: 20 years old or older
ECOG Performance Status (PS); 0-2
Key exclusion criteria
Besides the above
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Itou |
Organization
shinshu University
Division name
surgery 2
Zip code
Address
Asahi 3-1-1 matumoto
TEL
0263-35-4600
tashiina@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Shiina |
Organization
shinshu University
Division name
thoracic surgery
Zip code
Address
Asahi 3-1-1 matumoto
TEL
0263-35-4600
Homepage URL
tashiina@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University thoracic surgery
Institute
Department
Personal name
Funding Source
Organization
Shinshu University surgery2
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 01 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | 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 | 12 | Month | 07 | Day |
Last modified on
| 2017 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005277
