UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012413 |
|---|---|
| Receipt number | R000014529 |
| Scientific Title | A phase II trial of induction CDDP plus TS-1 with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 squamous-cell non-small cell lung cancer |
| Date of disclosure of the study information | 2013/11/27 |
| Last modified on | 2014/12/05 13:55:15 |
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Basic information
Public title
A phase II trial of induction CDDP plus TS-1 with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 squamous-cell non-small cell lung cancer
Acronym
Personalized Induction Therapy Clinical Trial-2(PIT-2)
Scientific Title
A phase II trial of induction CDDP plus TS-1 with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 squamous-cell non-small cell lung cancer
Scientific Title:Acronym
Personalized Induction Therapy Clinical Trial-2(PIT-2)
Region
| Japan |
Condition
Condition
Stage IIIA-N2 Squamous, Non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A phase II trial of induction CDDP plus TS-1 with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 squamous celll carcinoma of the lung.
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Induction concurrent chemoradiotherapy (CDDP +TS-1+ RT45Gy)
The surgical resection is performed after 3 cycles of chemotherapy with CDDP, TS-1 and RT45Gy.
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 proven squamous cel carcinoma of the lung, 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 > 800ml after lung resection , SpO2 (Room air) >95%
(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 Bc antibody or hepatitis Bs antigen positive
(9) Therapeutic anticoagulation; regular use of aspirin (>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 | Kenji Suzuki |
Organization
Juntendo University
Division name
Thoracic Surgery
Zip code
Address
3-1-3Hongo Bunkyo-ku,Tokyo
TEL
03-3813-3111
kjsuzuki@juntendo.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
ktakamo@juntendo.ac.jp
Sponsor or person
Institute
Advanced Clinical Trial chest surgery Group (ACTG)
Institute
Department
Personal name
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
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
がん研有明病院（東京都）
岐阜大学医学部附属病院（岐阜県）
九州大学病院（福岡県）
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）
富山大学附属病院（富山県）
がん・感染症センター都立駒込病院（東京都）
広島市立広島市民病院（広島県）
広島大学病院（広島県）
山形県立中央病院（山形県）
山口大学（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 | 11 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 27 | Day |
Last modified on
| 2014 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014529
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