UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008613 |
|---|---|
| Receipt number | R000010123 |
| Scientific Title | Phase I trial of Bevacizumab and S-1 chemotherapy for patients with previously treated advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2012/08/06 |
| Last modified on | 2021/02/10 11:47:07 |
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Basic information
Public title
Phase I trial of Bevacizumab and S-1 chemotherapy for patients with previously treated advanced non-small cell lung cancer
Acronym
Bevacizumab and S-1 for previously treated advanced non-small cell lung cancer
Scientific Title
Phase I trial of Bevacizumab and S-1 chemotherapy for patients with previously treated advanced non-small cell lung cancer
Scientific Title:Acronym
Bevacizumab and S-1 for previously treated advanced non-small cell lung cancer
Region
| Japan |
Condition
Condition
Previously treated non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of Bevacizumab and S-1
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
safety
Key secondary outcomes
Overall survival, objective response rate , progression free survival
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
bevacizumab and 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically confirmed Stage IIIB/IV non-squamous non-small cell lung cancer
2) Previously treated one or more chemotherapy regimens
3) With one or more measurable disease based on RECIST (ver.1.1)
4) Performance Status (ECOG) : 0-1
5) 20<= years
6) Patients providing written informed consent
7) Adequate function of vital organs, including normal hematopoietic liver
and renal function as following:
WBC >= 3,000/mm3 or Neutrophils >= 1,500/mm3
Hemoglobin >= 9.0 g/dL
Platelets >= 100,000/mm3
AST and ALT, x 2.5 of upper limit of normal (ULN) or less.
Total bilirubin <= 1.5mg/mL
Serum creatinine <= 1.5mg/dL
Creatinin crealance>=30mL/min
PT-INR <1.5
Urinary protein <2+
PaO2>=60torr or SpO2>=95%
8)interval:
(1) chemotherapy, more than 3 weeks after the last chemotherapy.
(2) Radiation, more than 12 weeks after the thoracic irradiation or more than 2 weeks after the last irradiation to other organs.
(3) Operation, more than 4 weeks after the last operation (including pleurodesis)
9) A life expectancy of more than 3 months
Key exclusion criteria
1)Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
2)Patients with uncontrollable complications(e.g. uncontrollable heart disease, severe arrhythmia, continuous diarrhea).
3)Patients with active severe infections.
4)History of active double cancer within 5 years prior to the study.
6)Patients with symptomatic brain metastasis
7)
8)History of hemoptysis with 2.5mL or more and Continued bloody phlegm.
9)Pregnancy or lactation
10)evidence of bleeding diathesis or coagulopathy
11)tumor invasive to the chest large blood vessel. Cavity in brain or lung tumor
12)current or previous (within the last 1 year) history of GI perforation
13)current history of uncontrorable hypertension
14)Impossible cases with oral administration.
15)severe drug allergy for 5-FU or UFT or S-1 content medicine
16) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Nishio |
Organization
Cancer Institute Hospital of Japanese Foudation for Ccancer Research
Division name
Toracic Medical Oncology
Zip code
Address
3-8-31 Ariake Kotoku Tokyo Japan
TEL
03-3520-0111
mnishio@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Horiike |
Organization
Cancer Institute Hospital of Japanese Foudation for Ccancer Research
Division name
Toracic Medical Oncology
Zip code
Address
3-8-31 Ariake Kotoku Tokyo Japan
TEL
03-3520-0111
Homepage URL
atsushi.horiike@jfcr.or.jp
Sponsor or person
Institute
Thoracic Medical Oncology
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Toracic Medical Oncology
Cancer Institute Hospital of Japanese Foudation for Ccancer Research
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
| 2012 | Year | 08 | Month | 06 | 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
| 2012 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 05 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 04 | Day |
Last modified on
| 2021 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010123
