UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004278 |
|---|---|
| Receipt number | R000004308 |
| Scientific Title | A feasibility study of neoadjuvant therapy with cisplatin, pemetrexed, and bevacizumab (Avastin®) in patients with non-squamous non small cell lung cancer (NAVAL study) |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2019/07/29 12:09:52 |
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Basic information
Public title
A feasibility study of neoadjuvant therapy with cisplatin, pemetrexed, and bevacizumab (Avastin®) in patients with non-squamous non small cell lung cancer (NAVAL study)
Acronym
A feasibility study of neoadjuvant therapy with cisplatin, pemetrexed, and bevacizumab (Avastin®) in patients with non-squamous non small cell lung cancer (NAVAL study)
Scientific Title
A feasibility study of neoadjuvant therapy with cisplatin, pemetrexed, and bevacizumab (Avastin®) in patients with non-squamous non small cell lung cancer (NAVAL study)
Scientific Title:Acronym
A feasibility study of neoadjuvant therapy with cisplatin, pemetrexed, and bevacizumab (Avastin®) in patients with non-squamous non small cell lung cancer (NAVAL study)
Region
| Japan |
Condition
Condition
Non-squamous non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the feasibility of neoadjuvant combination therapy of Cisplatin, Pemetrexed, and Bevacizumab in patients with resectable clinical stage II/IIIA non-squamous non-small cell lung cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Pathological complete resection rate
Key secondary outcomes
Relapse free survival, 2Y,5Y survival, Response rate, Adverse event
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
After Cisplatin (75mg/m2) + Pemetrexed (500mg/m2) + Bevacizumab (15mg/kg) day 1 q3w 3 cycles, lung resection with lymph node dissection
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. Histologically or pathologically proven non-squamous non-small cell lung cancer
2. Resectable clinical stage II/IIIA (UICC-7)
3. Without previously treatment for lung cancer
4. Age >=20, <75 y
5. ECOG PS 0-1
6. Expected FEV 1.0 > 1.0L after lung resection
7. Adequate organ function
8. Written informed consent
Key exclusion criteria
1. Uncontrollable systemic disease (hyper tension or diabetes mellitus)
2. Current history of hemosputum or hemoptysis
3. Evidence of bleeding diathesis or coagulopathy
4. Cavity in lung tumor or great vessel involvement
5. Current or previous (within the last 1 year) history of cerebrovascular disease
6. Traumatic fracture of un recovery
7. History of active infection
8. Therapeutic anticoagulation; regular use of aspirin (>325 mg/day)
9. Severe GI disease
10. Current or previous (within the last 1 year) history of GI perforation or diverticultis
11. History of severe heart disease
12. Severe diarrhea
13. Severe drug allergy
14. Interstitial pneumonia or pulmonary fibrosis detectable on chest Xp
15. History of active double cancer
16. History of pregnancy or lactation
17. Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Morihito |
| Middle name | |
| Last name | Okada |
Organization
Hiroshima University Hospital
Division name
Thoracic Surgery
Zip code
734-8551
Address
Hiroshima
TEL
0822575869
morihito@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Tsutani |
Organization
Hiroshima University Hospital
Division name
Thoracic Surgery
Zip code
734-8551
Address
Hiroshima
TEL
0822575869
Homepage URL
tsutani@hiroshima-u.ac.jp
Sponsor or person
Institute
Thoracic Surgery, Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
082-257-5907
gaku-hiroshimajimu@office.hiroshima-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
広島大学病院（広島県)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000004308
Publication of results
Published
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000004308
Number of participants that the trial has enrolled
31
Results
See the attached file.
Results date posted
| 2019 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
See the attached file.
Participant flow
See the attached file.
Adverse events
See the attached file.
Outcome measures
See the attached file.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2010 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 28 | Day |
Last modified on
| 2019 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004308
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/07/29 | NAVAL ver 1.1.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2019/07/29 | NAVAL試験【C...pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/07/29 | Presentation NAVAL (ver 3 1).pptx |
