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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006351
Receipt No. R000007532
Scientific Title Feasibility study of a postoperative adjuvant chemotherapy which performs the maintenance therapy of TS-1 after CBDCA+TS-1 to the patients of pathological stage II-IIIA with completely resected non-small cell lung cancer
Date of disclosure of the study information 2011/09/15
Last modified on 2017/03/20

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Basic information
Public title Feasibility study of a postoperative adjuvant chemotherapy which performs the maintenance therapy of TS-1 after CBDCA+TS-1 to the patients of pathological stage II-IIIA with completely resected non-small cell lung cancer
Acronym Escargot001
Scientific Title Feasibility study of a postoperative adjuvant chemotherapy which performs the maintenance therapy of TS-1 after CBDCA+TS-1 to the patients of pathological stage II-IIIA with completely resected non-small cell lung cancer
Scientific Title:Acronym Escargot001
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Hematology and clinical oncology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Feasibility study of a postoperative adjuvant chemotherapy which performs the maintenance therapy of TS-1 after CBDCA+TS-1 to the patients of pathological stage II-IIIA with completely resected non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes treatment completion rate
Key secondary outcomes survival period, overall survival, recurrence form, adversed event

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After CBDCA(AUC=5, day1) +TS-1(80mg/m2, day1-14) q3-4w, 3 courses, TS-1 80mg/m2 b.i.d., day 1-14 q3w, for 6 months
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) pathologically proven Non-small Cell Lung Cancer
2) pathological stage II, IIIA
3) complete resection
4) at least lobectomy
5) LN dissection (ND2a) or Elective Lymph Node Dissection
6) no prior anti cancer treatment for thoracic malignancy except for this operation
7) ECOG PS 0-1
8) more than 20 years of age, under 75 years of age
9) adequate organ function
10) within 10 weeks after surgery
11) signed informed consent
Key exclusion criteria 1) not recovered from surgical complications
2) active infection such as bacterial infection
3) patients with interstitial pneumonaitis or pulmonary fibrosis, as determined by chest CT
4) patients with myocardial infraction within 6 months
5) patinets with uncontroled complications
6) grade 2 or greater peripheral neuropathy
7) active concomitant malignancy
8) pregnant or lactating woman
9) concomitant therapy with flucytocine
10) other conditions not suitable for this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyuki Matsutani
Organization Teikyo University
Division name Department of Surgery
Zip code
Address Kaga 2-11-1, Itabashi-ku, Tokyo, Japan 173-8606
TEL 03-3964-1231
Email matsutani1970@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhiko Seki
Organization Teikyo University
Division name Oncology Division
Zip code
Address Kaga 2-11-1, Itabashi-ku, Tokyo, Japan 173-8606
TEL 03-3964-1231
Homepage URL
Email matsutani1970@yahoo.co.jp

Sponsor
Institute Escargot
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2011 Year 09 Month 15 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 No longer recruiting
Date of protocol fixation
2011 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 09 Month 15 Day
Last modified on
2017 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007532

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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