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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014386
Receipt No. 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

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Basic information
Public 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.
Acronym Superior sulcus tumor Induction Therapy Clinical Trial(SST)
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.
Scientific Title:Acronym Superior sulcus tumor Induction Therapy Clinical Trial(SST)
Region
Japan

Condition
Condition Superior sulcus tumor
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 3-year overall survival
Key secondary outcomes 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

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 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+RT66Gy)
The surgical resection is performed after 3 cycles of chemotherapy with CDDP,TS-1 and RT45Gy(2Gy/fra/day,33fractions).
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

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-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
Key exclusion criteria (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
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Tsuboi
Organization National Cancer Center Hospital East
Division name Thoracic Surgery
Zip code
Address 6-5-1Kashiwanoha kasiwashi,Chiba
TEL 04-7133-1111
Email 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
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 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)

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 26 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
2014 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 07 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
2014 Year 06 Month 26 Day
Last modified on
2014 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016744


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