Unique ID issued by UMIN | UMIN000011941 |
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Receipt number | 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 16:11:10 |
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
Personalized Induction Therapy Clinical Trial-1:PIT-1
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
Personalized Induction Therapy Clinical Trial-1:PIT-1
Japan |
Stage IIIA-N2 Non-squamous, Non-small cell lung cancer
Chest surgery |
Malignancy
NO
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
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
2-year progression-free survival
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
Interventional
Parallel
Randomized
Open -no one is blinded
Active
YES
YES
Institution is considered as a block.
YES
Central registration
2
Treatment
Medicine |
"Group A : Induction chemotherapy (CDDP + PEM + BEV)
The surgical resection is performed after 3 cycles of chemotherapy with CDDP, PEM, and bevacizumab.
"
"Group B :Induction concurrent chemoradiotherapy (CDDP + PEM + RT45Gy)
The surgical resection is performed after 3 cycles of chemotherapy with CDDP, PEM and RT45Gy.
"
20 | years-old | <= |
75 | years-old | >= |
Male and Female
"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
"
"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
"
80
1st name | |
Middle name | |
Last name | Morihito Okada |
Hiroshima University
Thoracic Surgery
1-2-3 kasumi minami-ku Hiroshima,Hiroshima
082-257-5869
morihito@hiroshima-u.ac.jp
1st name | |
Middle name | |
Last name | Kazuya Takamochi |
Juntendo University
Thoracic Surgery
3-1-3Hongo Bunkyo-ku,Tokyo
03-3813-3111
ktakamo@juntendo.ac.jp
Advanced Clinical Trial chest surgery Group (ACTG)
None
Self funding
NO
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)
2013 | Year | 10 | Month | 02 | Day |
Unpublished
No longer recruiting
2013 | Year | 08 | Month | 16 | Day |
2013 | Year | 10 | Month | 01 | Day |
2013 | Year | 10 | Month | 02 | Day |
2018 | Year | 09 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013941
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