UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005921 |
|---|---|
| Receipt number | 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 | 2020/12/01 11:55:24 |
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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
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
akamine.s@oitakenbyo.jp
Sponsor or person
Institute
Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007002
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