UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004278
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email tsutani@hiroshima-u.ac.jp

Sponsor
Institute Thoracic Surgery, Hiroshima University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.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


Contact us.