UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011205 |
|---|---|
| Receipt number | R000013133 |
| Scientific Title | Efficacy study of carboplastin/TS-1 during postoperative adjuvant chemotherapy after complete resection of non-small cell lung cancer at pathological stage II and IIIA in elderly patients older than 75 years old |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2022/07/24 15:44:37 |
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Basic information
Public title
Efficacy study of carboplastin/TS-1 during postoperative adjuvant chemotherapy after complete resection of non-small cell lung cancer at pathological stage II and IIIA in elderly patients older than 75 years old
Acronym
escargot 002
Scientific Title
Efficacy study of carboplastin/TS-1 during postoperative adjuvant chemotherapy after complete resection of non-small cell lung cancer at pathological stage II and IIIA in elderly patients older than 75 years old
Scientific Title:Acronym
escargot 002
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of carboplastin combined with tegafur-gimeracil-oteracil potassium combination drug (TS-1) use during postoperative adjuvant chemotherapy was studied after complete resection of non-small cell lung cancer at pathological stage II and IIIA in elderly patients older than 75 years old.
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
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
CBDCA+TS-1
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Cases which have been diagnosed with non-small cell lung cancer pathologically. Low malignant potential tumors and large-cell neuroendocrine carcinoma such as cartinoid tumor, mucoepidermoid carcinoma and adenoid cystic carcinoma are excluded.
2) Cases which are at pathological stages II and IIIA
3) Cases in which complete removal of a tumor has been confirmed pathologically by a surgeon.
4) Cases in which surgical resection including lobectomy or more has been performed. Cases which have undergone bronchoplasty are included.
5) Cases in which hilar and mediastinal lymph node dissection have been performed.
6) Cases in which no treatments excluding surgical treatments have been performed.
7) Cases with the performance status of between 0 and 1.
8) Cases older than 75 years old.
9) Cases indicating following organ (bone marrow, liver, kidney and lung) functions
10) Cases in which chemotherapy can be initiated within 10 weeks after surgery
11) Cases in which a consent form for participating the study has been signed by a patient.
Key exclusion criteria
1) Cases in which patients have not been recovered from a complication after surgery
2) Cases in which active infections such as bacterial infections have occurred.
3) Cases in which the presence of pulmonary fibrosis or interstitial pneumonia (pathologically active interstitial pneumonia after surgery) has been confirmed.
4) Cases in which myocardial infarction occurred within the last 6 months
5) Cases with complications which are hard to control (such as cardiac disease, liver disease, severe diabetes and hemorrhage).
6) Cases with peripheral neuropathy of above Grade 2
7) Cases with active double cancer (synchronous double cancer and metachronous double cancer with 5 years of disease-free period).
8) Cases during flucytosine treatment (the co-administration of TS-1 is prohibited).
9) Other cases in which a primary physician considered not to be suitable for the study.
Target sample size
26
Research contact person
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
matsutan@med.teikyo-u.ac.jp
Public contact
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
turb-office@teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University School of Medicine
Institute
Department
Personal name
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
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
エスカルゴ００２
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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 17 | Day |
Last modified on
| 2022 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013133
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