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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011205
Receipt No. R000013133
Scientific Title Efficacy study of carboplastin/TS-1 during postoperative adjuvant chemotherapy after complete resection of non-small cell lung cancer at pathological stage II and IIIA in elderly patients older than 75 years old
Date of disclosure of the study information 2013/08/01
Last modified on 2018/09/13

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Basic information
Public title Efficacy study of carboplastin/TS-1 during postoperative adjuvant chemotherapy after complete resection of non-small cell lung cancer at pathological stage II and IIIA in elderly patients older than 75 years old
Acronym escargot 002
Scientific Title Efficacy study of carboplastin/TS-1 during postoperative adjuvant chemotherapy after complete resection of non-small cell lung cancer at pathological stage II and IIIA in elderly patients older than 75 years old
Scientific Title:Acronym escargot 002
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology Chest surgery
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Efficacy of carboplastin combined with tegafur-gimeracil-oteracil potassium combination drug (TS-1) use during postoperative adjuvant chemotherapy was studied after complete resection of non-small cell lung cancer at pathological stage II and IIIA in elderly patients older than 75 years old.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Treatment completion rate
Key secondary outcomes Overall survival period (OS), Recurrence free survival period (RFS), Adverse effect occurrence rate, recurrence pattern

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 CBDCA+TS-1
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Cases which have been diagnosed with non-small cell lung cancer pathologically. Low malignant potential tumors and large-cell neuroendocrine carcinoma such as cartinoid tumor, mucoepidermoid carcinoma and adenoid cystic carcinoma are excluded.
2) Cases which are at pathological stages II and IIIA
3) Cases in which complete removal of a tumor has been confirmed pathologically by a surgeon.
4) Cases in which surgical resection including lobectomy or more has been performed. Cases which have undergone bronchoplasty are included.
5) Cases in which hilar and mediastinal lymph node dissection have been performed.
6) Cases in which no treatments excluding surgical treatments have been performed.
7) Cases with the performance status of between 0 and 1.
8) Cases older than 75 years old.
9) Cases indicating following organ (bone marrow, liver, kidney and lung) functions

10) Cases in which chemotherapy can be initiated within 10 weeks after surgery
11) Cases in which a consent form for participating the study has been signed by a patient.
Key exclusion criteria 1) Cases in which patients have not been recovered from a complication after surgery
2) Cases in which active infections such as bacterial infections have occurred.
3) Cases in which the presence of pulmonary fibrosis or interstitial pneumonia (pathologically active interstitial pneumonia after surgery) has been confirmed.
4) Cases in which myocardial infarction occurred within the last 6 months
5) Cases with complications which are hard to control (such as cardiac disease, liver disease, severe diabetes and hemorrhage).
6) Cases with peripheral neuropathy of above Grade 2
7) Cases with active double cancer (synchronous double cancer and metachronous double cancer with 5 years of disease-free period).
8) Cases during flucytosine treatment (the co-administration of TS-1 is prohibited).
9) Other cases in which a primary physician considered not to be suitable for the study.
Target sample size 26

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Noriyuki Matsutani
Organization Teikyo University School of Medicine
Division name Surgery
Zip code
Address 2-11-1 Kaga, Itabashi-ku Tokyo
TEL 03-3964-1231
Email matsutan@med.teikyo-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Noriyuki Matsutani
Organization Teikyo University School of Medicine
Division name Surgery
Zip code
Address 2-11-1 Kaga, Itabashi-ku Tokyo
TEL 03-3964-1231
Homepage URL
Email turb-office@teikyo-u.ac.jp

Sponsor
Institute Teikyo University School of Medicine
Institute
Department

Funding Source
Organization Teikyo University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Saitama Medical Center
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 エスカルゴ002

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 01 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
2013 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2013 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
2013 Year 07 Month 17 Day
Last modified on
2018 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013133

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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