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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011210
Receipt No. R000013140
Scientific Title Randomized Phase II trial on conventional administration (continuous administration for 2 weeks followed by one week interval) and alternate-day administration of adjuvant chemotherapy drug TS-1 in patients who underwent complete resection of non-small cell lung cancer.
Date of disclosure of the study information 2013/08/01
Last modified on 2018/03/01

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Basic information
Public title Randomized Phase II trial on conventional administration (continuous administration for 2 weeks followed by one week interval) and alternate-day administration of adjuvant chemotherapy drug TS-1 in patients who underwent complete resection of non-small cell lung cancer.
Acronym conventional administration (continuous administration for 2 weeks followed by one week interval) vs alternate-day administration
Scientific Title Randomized Phase II trial on conventional administration (continuous administration for 2 weeks followed by one week interval) and alternate-day administration of adjuvant chemotherapy drug TS-1 in patients who underwent complete resection of non-small cell lung cancer.
Scientific Title:Acronym conventional administration (continuous administration for 2 weeks followed by one week interval) vs alternate-day administration
Region
Japan

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

Objectives
Narrative objectives1 Comparison of the conventional administration (continuous administration for 2 weeks followed by one week interval) and the alternate-day administration of adjuvant chemotherapy drug TS-1 after surgery and determination of the optimum administration method of the drug.
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 Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 conventional administration (continuous administration for 2 weeks followed by one week interval)
Interventions/Control_2 alternate-day administration
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) Cases with a complete resection of primary non-small cell lung cancer.
2) Cases with histopathologically identified adenocarcinoma, large-cell cancer, squamous cell cancer and adenosquamous cancer.
3) Cases at stage I (excluding T1a) according to the New TNM Staging System for Lung Cancer (UICC-7)
4) Cases with age between 20 and 80 years old
5) Cases with performance status (ECOG scale) of between 0 and 1.
6) Cases with the following main organ functions
7) Cases in which chemotherapy can be performed within 8 weeks after surgery.
8) Cases in which no treatments excluding surgery have be performed.
9) Cases in which oral administration of drugs can be possible.
10) Cases in which a consent form to participate in the study has been signed by a patient.
Key exclusion criteria 1) Cases in which apparent interstitial pneumonia or pulmonary fibrosis is observed by routine chest radiograph or chest CT.
2) Cases which require drainage of accumulated pleural fluid, ascetic fluid and effusion.
3) Cases with synchronous or metachronous active double cancer or multiple cancer.
4) Cases with complications which are hard to control (such as cardiac disease, liver disease, severe diabetes and hemorrhage).
5) Cases accompanied with diarrhea (watery diarrhea).
6) Patients who are pregnant or nursing or women who might be pregnant.
7) Male patients planning to have a child.
8) Patients with prior drug hypersenstitivity.
9) Patients with history of severe hypersensitivity to TS-1 components.
10) Patients who are undergoing a treatment with other fluorinated pyrimidine-type anti-tumor drugs.
11) Patients in which the administration of TS-1 is prohibited.
12) Patients who are undergoing a treatment with warfarin potassium, phenytoin or flucytosine.
13) Other cases which are determined to be unsuitable to this study
Target sample size 80

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 matsutan@med.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

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 05 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 08 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 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013140

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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