UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2007 Year 01 Month 09 Day
Date of IRB	2007 Year 02 Month 23 Day
Anticipated trial start date	2007 Year 05 Month 31 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	2020 Year 12 Month 01 Day

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