UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005921
Receipt No. R000007002
Scientific Title Effect of adjuvant chemotherapy for stage IA vessel invasion positive non-small cell lung cancer
Date of disclosure of the study information 2011/07/05
Last modified on 2016/10/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of adjuvant chemotherapy for stage IA vessel invasion positive non-small cell lung cancer
Acronym Adjuvant chemotherapy for stage IA vessel invasion positive NSCLC
Scientific Title Effect of adjuvant chemotherapy for stage IA vessel invasion positive non-small cell lung cancer
Scientific Title:Acronym Adjuvant chemotherapy for stage IA vessel invasion positive NSCLC
Region
Japan

Condition
Condition Patients with completely resected stage IA NSCLC, in which vessel invasions are observed
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective is to improve the survival rate by adjuvant chemotherapy with UFT in the patients with completely resected stage IA vessel invasion positive non-small cell lung caner
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 5-year survival rate
Key secondary outcomes Completion rate, recurrent rate, drug toxicity, 3-year survival rate, 3- and 5-year disease free survival rates.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 From four to eight week, adjuvant chemotherapy with UFT start until 2 years
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
45 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Patients with obtained informed consent
2.Non-small cell lung cancer (NSCLC) with histological proof
3.Pathological stage IA NSCLC after complete resection(include intensive limited resection)4.Positive lymphatic or blood vessel invasion
5.First therapy
6.No prior treatment except for surgery
7.Age=>45and <80 years
8.No active double cancer
9.Patients who can be orally administrated
10.Performance status 0 or 1
11.Patients also had to have adequate organ function (within 14 days before entry 4000=<leukocytes=<12,000/mm3,
Hemoglobin>=10.0g/dl
thrombocytes>=100,000/mm3
GOT and GPT less than twice the normal limits at each institution
blood urea nitrogen=<25 mg/dl
creatinine less than the normal limits at each institution
Key exclusion criteria 1.Patients with drug allergy
2. Patients with contraindication of UFT administration
3.Patients with severe complication (bowel paralysis,ileus,pneumonia,emphysema,lung fibrosis or interstitial pneumonia,uncontrollable DM,heart failure,renal failure,and liver failure)4.Patients with watery diarrhea
5.Women who have possibility(will)with gestation and pregnant or breast feeding women
6.Men who have will with making bady
7.Doctor judged inadequate patients
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akamine Shinji
Organization Oita Prefectural Hospital
Division name Chest surgery
Zip code
Address 476 Oita bunyou 870-8511
TEL 097-546-7111
Email akamine.s@oitakenbyo.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akamine Shinji
Organization Oita Prefectural Hospital
Division name Chest surgery
Zip code
Address 476 Bunyo Oita-city 870-8511
TEL 097-546-7111
Homepage URL
Email akamine.s@oitakenbyo.jp

Sponsor
Institute Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

Funding Source
Organization Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 07 Month 05 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
2007 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2007 Year 02 Month 01 Day
Last follow-up date
2017 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 07 Month 05 Day
Last modified on
2016 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007002

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.