UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010681 |
|---|---|
| Receipt number | R000012488 |
| Scientific Title | Multicenter randomized phase II study of cisplatin+pemetrexed+bevacizmab followed by maintenance pemetrexied with or without bevacizmab in patients chemoterapy-naive advanced non-squamous non-small cell lung cancer with wild type EGFR(TORG1321) |
| Date of disclosure of the study information | 2013/05/17 |
| Last modified on | 2021/11/08 11:07:55 |
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Basic information
Public title
Multicenter randomized phase II study of cisplatin+pemetrexed+bevacizmab followed by maintenance pemetrexied with or without bevacizmab in patients chemoterapy-naive advanced non-squamous non-small cell lung cancer with wild type EGFR(TORG1321)
Acronym
Randomized phase II study of CDDP+PEM+BEV followed by maintenance PEM with or without BEV in patients with chemotherapy-naive advanced non-squamous NSCLC with wild type EGFR(TORG1321)
Scientific Title
Multicenter randomized phase II study of cisplatin+pemetrexed+bevacizmab followed by maintenance pemetrexied with or without bevacizmab in patients chemoterapy-naive advanced non-squamous non-small cell lung cancer with wild type EGFR(TORG1321)
Scientific Title:Acronym
Randomized phase II study of CDDP+PEM+BEV followed by maintenance PEM with or without BEV in patients with chemotherapy-naive advanced non-squamous NSCLC with wild type EGFR(TORG1321)
Region
| Japan |
Condition
Condition
Chemotherapy-naive advanced non-squamous non-samll cell lung cancer with wild type EGFR
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To compare the efficacy and the safety of maintenance PEM and PEM+BEV
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival of maintenance therapy
Key secondary outcomes
Progression free survival from induction therapy,
Overall survival from induction and maintenance therapy,
Response rate of induction and maintenance therapy,
Disease control rate of induction and maintenance therapy,
1 year survival rate of induction and maintenance therapy,
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CDDP 75mg/m2 + PEM 500mg/m2 + BEV 15mg/kg day 1 x 4 cycles q3wks followed byPEM 500mg/m2 q3wks until PD
Interventions/Control_2
CDDP 75mg/m2 + PEM 500mg/m2 + BEV 15mg/kg day 1 x 4 cycles q3wks followed byPEM 500mg/m2 BEV 15mg/kg q3wks until PD
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
First step(induction)
1)Histologically or cytologically proven non-squamous non-small cell lung cancer
2)Wild type EGFR
3)Stage IIIB,stageIV without any indications for radiotherapy
4)No prior chemotherapy
5)ECOG performance status 0-1
6)With one or more measurable disease (RECIST ver.1.1)
7) Aged 20<=, <=74
8)Adequate organ function
9)In case of non-chest radiation, need more than two weeks interval after last radiation
10)Written informed concent
Second step (maintenance)
1)Non-PD patients after induction therapy
2)Adequate organ function after non-PD confirmation
3)ECOG performance status 0-1
Key exclusion criteria
First step(induction)
1)Symptomatic brain metastasis
2)Current history of hemoptysis
3)With pulmonary cavity
lesions
4)History of radical thoracic radiotherapy
5)Active infections diseases
6)Fever over 38 degrees centigrade
7)Serious complications
8)Massive pleural and cardiac effusion and ascites that need to be immediately treated
9)Active concomitant cancers
10)Severe drug allergy
11)Uncontrollable ulcer indigestive tract
12)Perforation of the digestive tract or history within the past one year
13)Receiving anticoagulant drug (325mg and less aspirin is possible)
14) Pregnancy, breastfeeding or suspected of being pregnant
15)Those judged to be not suitable by the attending physician
Second step (maintenance)
1)Symptomatic brain metastasis
2)Accompanied by serious complication in induction therapy
3) Severe drug allergy for PEM or BEM or severe adverse effect in induction therapy
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Mori |
Organization
Utsunomiya Memorial Hospital
Division name
Department of respiratory medicine
Zip code
320-0811
Address
1-3-16, Odori, Utsunomiya, Tochigi
TEL
028-622-1991
k.mori@nakayamakai.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kasai |
Organization
Tochigi cancer center
Division name
Department of respiratory medicine
Zip code
320-0834
Address
4-9-13, Yonan, Utsunomiya, Yochigi
TEL
028-658-5151
Homepage URL
http://www.torg.or.jp
takasai@tochigi-cc.jp
Sponsor or person
Institute
Thoracic Oncology Tesearch Group
Institute
Department
Personal name
Funding Source
Organization
Thoracic Oncology Tesearch Group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tochigi Cancer Center ethics committee
Address
4-9-13, Yonan, Utsunomiya, Yochigi
Tel
+81286585151
-
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 | 05 | Month | 17 | 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
108
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 09 | Day |
Last modified on
| 2021 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012488
