UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006351 |
|---|---|
| Receipt number | R000007532 |
| Scientific Title | Feasibility study of a postoperative adjuvant chemotherapy which performs the maintenance therapy of TS-1 after CBDCA+TS-1 to the patients of pathological stage II-IIIA with completely resected non-small cell lung cancer |
| Date of disclosure of the study information | 2011/09/15 |
| Last modified on | 2024/02/13 09:42:32 |
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Basic information
Public title
Feasibility study of a postoperative adjuvant chemotherapy which performs the maintenance therapy of TS-1 after CBDCA+TS-1 to the patients of pathological stage II-IIIA with completely resected non-small cell lung cancer
Acronym
Escargot001
Scientific Title
Feasibility study of a postoperative adjuvant chemotherapy which performs the maintenance therapy of TS-1 after CBDCA+TS-1 to the patients of pathological stage II-IIIA with completely resected non-small cell lung cancer
Scientific Title:Acronym
Escargot001
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Feasibility study of a postoperative adjuvant chemotherapy which performs the maintenance therapy of TS-1 after CBDCA+TS-1 to the patients of pathological stage II-IIIA with completely resected non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
treatment completion rate
Key secondary outcomes
survival period, overall survival, recurrence form, adversed event
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
After CBDCA(AUC=5, day1) +TS-1(80mg/m2, day1-14) q3-4w, 3 courses, TS-1 80mg/m2 b.i.d., day 1-14 q3w, for 6 months
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) pathologically proven Non-small Cell Lung Cancer
2) pathological stage II, IIIA
3) complete resection
4) at least lobectomy
5) LN dissection (ND2a) or Elective Lymph Node Dissection
6) no prior anti cancer treatment for thoracic malignancy except for this operation
7) ECOG PS 0-1
8) more than 20 years of age, under 75 years of age
9) adequate organ function
10) within 10 weeks after surgery
11) signed informed consent
Key exclusion criteria
1) not recovered from surgical complications
2) active infection such as bacterial infection
3) patients with interstitial pneumonaitis or pulmonary fibrosis, as determined by chest CT
4) patients with myocardial infraction within 6 months
5) patinets with uncontroled complications
6) grade 2 or greater peripheral neuropathy
7) active concomitant malignancy
8) pregnant or lactating woman
9) concomitant therapy with flucytocine
10) other conditions not suitable for this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Matsutani |
Organization
Teikyo University
Division name
Department of Surgery
Zip code
Address
Kaga 2-11-1, Itabashi-ku, Tokyo, Japan 173-8606
TEL
03-3964-1231
matsutani1970@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhiko Seki |
Organization
Teikyo University
Division name
Oncology Division
Zip code
Address
Kaga 2-11-1, Itabashi-ku, Tokyo, Japan 173-8606
TEL
03-3964-1231
Homepage URL
matsutani1970@yahoo.co.jp
Sponsor or person
Institute
Escargot
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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 | 09 | Month | 15 | 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
| 2011 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007532
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