Unique ID issued by UMIN | UMIN000014386 |
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Receipt number | R000016744 |
Scientific Title | A multicentre,single arm,confirmatory trial to evaluate the effectiveness of induction CDDP plus TS-1 with concurrent radiotherapy(66Gy) followed by surgical resection in patients with superior sulcus tumor. |
Date of disclosure of the study information | 2014/06/26 |
Last modified on | 2014/12/05 13:55:40 |
A multicentre,single arm,confirmatory trial to evaluate the effectiveness of induction CDDP plus TS-1 with concurrent radiotherapy(66Gy) followed by surgical resection in patients with superior sulcus tumor.
Superior sulcus tumor Induction Therapy Clinical Trial(SST)
A multicentre,single arm,confirmatory trial to evaluate the effectiveness of induction CDDP plus TS-1 with concurrent radiotherapy(66Gy) followed by surgical resection in patients with superior sulcus tumor.
Superior sulcus tumor Induction Therapy Clinical Trial(SST)
Japan |
Superior sulcus tumor
Chest surgery |
Malignancy
NO
A multicentre,single arm,confirmatory trial to evaluate the effectiveness of induction CDDP plus TS-1 with concurrent radiotherapy(66Gy) followed by surgical resection in patients with superior sulcus tumor.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
3-year overall survival
3-year and 5-year progression-free survival, 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
Single arm
Non-randomized
Open -no one is blinded
Active
1
Treatment
Medicine |
Induction concurrent chemoradiotherapy (CDDP+TS-1+RT66Gy)
The surgical resection is performed after 3 cycles of chemotherapy with CDDP,TS-1 and RT45Gy(2Gy/fra/day,33fractions).
20 | years-old | <= |
75 | years-old | >= |
Male and Female
(1)Histologically or cytologically proven non-small cell lung cancer,diagnosed using specimen material obtained from primary tumor or metastastatic lymph node.
(2)Chest MRI or thoracic CT,direct invasion of the primary lesion to the organ of one of the following is suspected.
a)Invasion to the first rib or more superior chest wall
b)Subclavian vein or subclavian artery
(3)cN0,cN1
(4)Patients with evaluable lesions or measurable disease.
(5)Age>=20,=<75y
(6)ECOG PS 0-1
(7)Expected FEV 1.0 > 800ml after lung resection,SpO2(Room air)>95%
(8)Adequate organ function
(9)Written informed consen
(1) Distant metastasis
(2) malignant pleural effusion, pericardial effusionintrathoracic seeding.
(3) Uncontrollable systemic disease (hyper tension, diabetes mellitus etc.)
(4) Case with the administration of the flucytosine.
(5) Severe drug allergy
(6) Infection requiring intravenous administration of anti-viral agents antibiotics, or antifungals
(7) Hepatitis Bs antigen positive
(8) History of severe heart disease , Current or previous (within the last 1 year) history of myocardial infarction
(9) Traumatic fracture of unrecovery ,a high degree of wound
(10) Severe diarrhea
(11) Investigational new drug or the unapproved drug is administered
(12) Interstitial pneumonia or pulmonary fibrosis detectable on chest CT
(13) History of active double cancer
(14) History of pregnancy or lactation or Women suspected of being pregnant.Men who wish to make a child. or no intention to contraception
(15) 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 | Masahiro Tsuboi |
National Cancer Center Hospital East
Thoracic Surgery
6-5-1Kashiwanoha kasiwashi,Chiba
04-7133-1111
kjsuzuki@juntendo.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
神奈川県立がんセンター(神奈川県)、がん研有明病院(東京都)、岐阜大学医学部附属病院(岐阜県)、九州がんセンター(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)、がん・感染症センター都立駒込病院(東京都)、広島大学病院(広島県)、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)、横浜市立大学附属市民総合医療センター(神奈川県)
2014 | Year | 06 | Month | 26 | Day |
Unpublished
Open public recruiting
2014 | Year | 05 | Month | 15 | Day |
2014 | Year | 07 | Month | 01 | Day |
2021 | Year | 09 | Month | 30 | Day |
2021 | Year | 12 | Month | 31 | Day |
2014 | Year | 06 | Month | 26 | Day |
2014 | Year | 12 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016744
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