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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011941
Receipt No. R000013941
Scientific Title A randomized phase II trial of induction CDDP +PEM +BEV versus CDDP + PEM with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 non-squamous- cell non-small cell lung cancer
Date of disclosure of the study information 2013/10/02
Last modified on 2018/09/04

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Basic information
Public title A randomized phase II trial of induction CDDP +PEM +BEV versus CDDP + PEM with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 non-squamous- cell non-small cell lung cancer
Acronym Personalized Induction Therapy Clinical Trial-1:PIT-1
Scientific Title A randomized phase II trial of induction CDDP +PEM +BEV versus CDDP + PEM with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 non-squamous- cell non-small cell lung cancer
Scientific Title:Acronym Personalized Induction Therapy Clinical Trial-1:PIT-1
Region
Japan

Condition
Condition Stage IIIA-N2 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 efficacy and safty of preoperative induction concurrent chemoradiotherapy(CDDP + PEM + RT45Gy) and preoperative induction chemotherapy (CDDP + PEM + BEV) for Stage IIIA-N2 non-squamous, non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 2-year progression-free survival
Key secondary outcomes 5-year progression-free survival
2-year and 5-year overall survival
Completion rate of the protocol treatment
Complete resection rate
Radiological response rate
Down staging rate
Safety
Pathological response (Ef)
Tumor markers (CEA/CYFRA)
SUVmax on FDG-PET scan

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 "Group A : Induction chemotherapy (CDDP + PEM + BEV)
The surgical resection is performed after 3 cycles of chemotherapy with CDDP, PEM, and bevacizumab.
"
Interventions/Control_2 "Group B :Induction concurrent chemoradiotherapy (CDDP + PEM + RT45Gy)
The surgical resection is performed after 3 cycles of chemotherapy with CDDP, PEM and RT45Gy.
"
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria "1. Histologically or cytologically proven non-squamous non-small cell lung cancer, diagnosed using specimen material obtained from primary tumor or metastastatic lymph node
2. Stage IIIA- pathologically proven N2 disease
3. Without previously treatment for lung cancer
4. Age 20-75 y
5. ECOG PS 0-1
6. Expected FEV 1.0 ,over800ml after lung resection, SpO2 Room air over95%
7. Adequate organ function
8. Written informed consent
"
Key exclusion criteria "1.Uncontrollable systemic disease.hyper tension, diabetes mellitus etc.
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. hepatitis B surface antigen positive
9. Therapeutic anticoagulation; regular use of aspirin ,over 325 mg/day.
10. Severe GI disease
11. Current or previous within the last 1 year history of GI perforation or diverticultis
12. History of severe heart disease
13. Severe diarrhea
14. Severe drug allergy
15. Investigational new drug or the unapproved drug is administered
16. Interstitial pneumonia or pulmonary fibrosis detectable on chest Xp
17. History of active double cancer
18. History of pregnancy or lactation
19. Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
"
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Morihito Okada
Organization Hiroshima University
Division name Thoracic Surgery
Zip code
Address 1-2-3 kasumi minami-ku Hiroshima,Hiroshima
TEL 082-257-5869
Email morihito@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuya Takamochi
Organization Juntendo University
Division name Thoracic Surgery
Zip code
Address 3-1-3Hongo Bunkyo-ku,Tokyo
TEL 03-3813-3111
Homepage URL
Email ktakamo@juntendo.ac.jp

Sponsor
Institute Advanced Clinical Trial chest surgery Group (ACTG)
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 大分大学医学部附属病院(大分県)
がん・感染症センター都立駒込病院(東京都)
がん研有明病院(東京都)
岐阜大学医学部附属病院(岐阜県)
倉敷中央病院(岡山県)
神戸大学医学部附属病院(兵庫県)
国立がん研究センター東病院(千葉県)
産業医科大学病院(福岡県)
順天堂大学医学部附属順天堂医院(東京都)
聖マリアンナ医科大学病院(神奈川県)
仙台厚生病院(宮城県)
東京医科大学病院(東京都)
鳥取大学医学部附属病院(鳥取県)
広島市立広島市民病院(広島県)
広島大学病院(広島県)
福島県立医科大学附属病院(福島県)
山形県立中央病院(山形県)
山口大学医学部附属病院(山口県)
横浜市立大学付属市民総合医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 02 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 08 Month 16 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 10 Month 02 Day
Last modified on
2018 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013941


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