UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010681
Receipt No. 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 2019/04/24

* 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 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
Middle name
Last name Kiyoshi Mori
Organization Tsuboi cancer center Hospital
Division name Department of respiratory medicine
Zip code
Address 1-10-13, Nagakubo, azumicho,Koriyama, Fukushima 963-0197
TEL 024-946-0808
Email kmori@tsuboi-hp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kasai
Organization Tochigi cancer center
Division name Department of respiratory medicine
Zip code
Address 4-9-13, Yonan, Utsunomiya, Yochigi, 320-0834
TEL 028-658-5151
Homepage URL http://www.torg.or.jp
Email takasai@tcc.pref.tochigi.lg.jp

Sponsor
Institute Thoracic Oncology Tesearch Group
Institute
Department

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
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 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
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 09 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012488

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.