UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011210 |
|---|---|
| Receipt number | R000013140 |
| Scientific Title | Randomized Phase II trial on conventional administration (continuous administration for 2 weeks followed by one week interval) and alternate-day administration of adjuvant chemotherapy drug TS-1 in patients who underwent complete resection of non-small cell lung cancer. |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2024/07/29 08:17:24 |
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Basic information
Public title
Randomized Phase II trial on conventional administration (continuous administration for 2 weeks followed by one week interval) and alternate-day administration of adjuvant chemotherapy drug TS-1 in patients who underwent complete resection of non-small cell lung cancer.
Acronym
conventional administration (continuous administration for 2 weeks followed by one week interval) vs alternate-day administration
Scientific Title
Randomized Phase II trial on conventional administration (continuous administration for 2 weeks followed by one week interval) and alternate-day administration of adjuvant chemotherapy drug TS-1 in patients who underwent complete resection of non-small cell lung cancer.
Scientific Title:Acronym
conventional administration (continuous administration for 2 weeks followed by one week interval) vs alternate-day administration
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the conventional administration (continuous administration for 2 weeks followed by one week interval) and the alternate-day administration of adjuvant chemotherapy drug TS-1 after surgery and determination of the optimum administration method of the drug.
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
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
conventional administration (continuous administration for 2 weeks followed by one week interval)
Interventions/Control_2
alternate-day administration
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) Cases with a complete resection of primary non-small cell lung cancer.
2) Cases with histopathologically identified adenocarcinoma, large-cell cancer, squamous cell cancer and adenosquamous cancer.
3) Cases at stage I (excluding T1a) according to the New TNM Staging System for Lung Cancer (UICC-7)
4) Cases with age between 20 and 80 years old
5) Cases with performance status (ECOG scale) of between 0 and 1.
6) Cases with the following main organ functions
7) Cases in which chemotherapy can be performed within 8 weeks after surgery.
8) Cases in which no treatments excluding surgery have be performed.
9) Cases in which oral administration of drugs can be possible.
10) Cases in which a consent form to participate in the study has been signed by a patient.
Key exclusion criteria
1) Cases in which apparent interstitial pneumonia or pulmonary fibrosis is observed by routine chest radiograph or chest CT.
2) Cases which require drainage of accumulated pleural fluid, ascetic fluid and effusion.
3) Cases with synchronous or metachronous active double cancer or multiple cancer.
4) Cases with complications which are hard to control (such as cardiac disease, liver disease, severe diabetes and hemorrhage).
5) Cases accompanied with diarrhea (watery diarrhea).
6) Patients who are pregnant or nursing or women who might be pregnant.
7) Male patients planning to have a child.
8) Patients with prior drug hypersenstitivity.
9) Patients with history of severe hypersensitivity to TS-1 components.
10) Patients who are undergoing a treatment with other fluorinated pyrimidine-type anti-tumor drugs.
11) Patients in which the administration of TS-1 is prohibited.
12) Patients who are undergoing a treatment with warfarin potassium, phenytoin or flucytosine.
13) Other cases which are determined to be unsuitable to this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Matsutani |
Organization
Teikyo University school of Medicine
Division name
Surgery
Zip code
173-8606
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 | Noriyuki |
| Middle name | |
| Last name | Matsutani |
Organization
Teikyo University School of Medicine
Division name
Surgery
Zip code
173-8606
Address
2-11-1 Kaga, Itabashi-ku Tokyo
TEL
03-3964-1231
Homepage URL
matsutan@med.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
Teikyo University school of medicine
Address
2-11-1Kaga, Itabashi Tokyo
Tel
03-3964-1211
turb-office@teikyo-u.ac.jp
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
| 2013 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.teikyo-u.ac.jp/affiliate/ethic_committee/approval_release
Publication of results
Unpublished
Result
URL related to results and publications
https://www.teikyo-u.ac.jp/affiliate/ethic_committee/approval_release
Number of participants that the trial has enrolled
59
Results
Test Cancellation
Results date posted
| 2024 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Test Cancellation
Participant flow
Test Cancellation
Adverse events
Test Cancellation
Outcome measures
Test Cancellation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2013 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 17 | Day |
Last modified on
| 2024 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013140
