UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014386
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

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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


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



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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016744


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name