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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011083
Receipt No. R000012973
Scientific Title CBDCA or CDDP/PEM/Bev as Induction Regimen Prior to Surgery in Patients With Non-SQ NSCLC Stage II and III
Date of disclosure of the study information 2013/08/01
Last modified on 2018/07/12

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Basic information
Public title CBDCA or CDDP/PEM/Bev as Induction Regimen Prior to Surgery in Patients With Non-SQ NSCLC Stage II and III
Acronym Modified NAVAL study
Scientific Title CBDCA or CDDP/PEM/Bev as Induction Regimen Prior to Surgery in Patients With Non-SQ NSCLC Stage II and III
Scientific Title:Acronym Modified NAVAL study
Region
Japan

Condition
Condition Non-squamous non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility of neoadjuvant combination therapy of Cisplatin or Carboplatin, 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 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 or Carboplatin + 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
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumihiro Tanaka
Organization UOEH
Division name Second Department of Surgery
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku,
TEL 093-691-7442
Email ftanaka@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name koushi kuroda
Organization UOEH
Division name Second Department of Surgery
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku,
TEL 093-691-7442
Homepage URL
Email kuroda-k@med.uoeh-u.ac.jp

Sponsor
Institute UOEH
Institute
Department

Funding Source
Organization UOEH
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
Email

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
2013 Year 08 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 Completed
Date of protocol fixation
2013 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 01 Day
Last follow-up date
2018 Year 08 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
2013 Year 07 Month 01 Day
Last modified on
2018 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012973

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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