UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012215 |
|---|---|
| Receipt number | R000014283 |
| Scientific Title | A phase II study of Cisplatin+Pemetrexed +Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR |
| Date of disclosure of the study information | 2013/11/05 |
| Last modified on | 2023/05/22 11:43:26 |
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Basic information
Public title
A phase II study of Cisplatin+Pemetrexed
+Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR
Acronym
A phase II study of Cisplatin+Pemetrexed
+Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR
Scientific Title
A phase II study of Cisplatin+Pemetrexed
+Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR
Scientific Title:Acronym
A phase II study of Cisplatin+Pemetrexed
+Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR
Region
| Japan |
Condition
Condition
Non-small cell lung cancer(Non squamous)
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the he response rate and feasibility of Carboplatin+Pemetrexed+Bevacizumab in patients with Gefitinib refractory non-squamous Non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
PFS,OS,Beyond PD lesion Response Rate: BPRR
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cisplatin+Pemetrexed+Bevacizumab every 3 weeks. Responding patients receive Pemetrexed+Bevacizumab maintenance.EGFR-TKI continue until PD.
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 cytologically confirmed non-squamous NSCLC with activating EGFR-mutations
2. no previous chemotherapy
3. Stage IIIB, VI
4. measurable disease
5. 75>age >=20 years
6. performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale
7. adequate organ function
adequate bone marrow (neutrophil count > =1,500/mm3, hemoglobin concentration > =9.0g/dL, platelet count >= 100,000 /mL), kidney (creatinine>= Cr 60), liver (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] < =institutional normal level x 2.5, total bilirubin< =institutional normal level x 1.5 ), SpO2> =90%, Proteinuria< 1+
8. PD after EGFR-TKI treatment more than 6 month
Key exclusion criteria
1. Medication with anti-coagulative
2.Active infection or other serious conditions
3. Severe pleural effusion or uncontrollable pleural effusion
4.Symptomatic brain metastasis
5. Uncontrollable hypertension
6. Uncontrollable diabetes mellitus
7. Current or previous history of hemoptysis or hemosputum
8. Current or previous (within the last 1 year) history of GI perforation
9. Interstitial pneumonia or pulmonary fibrosis detectable on CT scan
10.Tumor invasive to the chest large blood vessel.
11.Evidence of bleeding diathesis or coagulopathy
12.History of active double cancer
13.History of active psychological disease
14.History of pregnancy or lactation
15. Active concomitant malignancy
16. Active mental illness
17. Previous treatment with Carboplatin or Pemetrexed or Bevacizumab
18. History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris etc)
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohisa Yoshizawa |
Organization
Niigata University Medical and Dental Hospital
Division name
Bioscience Medical Research Center
Zip code
Address
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL
025-227-2517
hy0522@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohisa Yoshizawa |
Organization
Niigata University Medical and Dental Hospital
Division name
Bioscience Medical Research Center
Zip code
Address
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL
025-227-2517
Homepage URL
hy0522@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata Lung Cancer Treatment Group
Institute
Department
Personal name
Funding Source
Organization
Niigata Foundation for the Promotion of Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
燕労災病院（新潟県）
厚生連長岡中央綜合病院（新潟県）
国立病院機構西新潟中央病院（新潟県）
済生会新潟第二病院（新潟県）
上越総合病院（新潟県）
新潟県立がんセンター（新潟県）
新潟県立吉田病院（新潟県）
新潟県立新発田病院（新潟県）
新潟県立中央病院（新潟県）
新潟市民病院（新潟県）
新潟大学医歯学総合病院（新潟県）
新潟労災病院（新潟県）
長岡赤十字病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 05 | 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
| 2013 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 05 | Day |
Last modified on
| 2023 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014283
