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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001658 |
Receipt No. | R000001999 |
Scientific Title | A randomized controlled Phase II study comparing TS-1 alone with CDDP+TS-1 as postoperative adjuvant chemotherapy in non-small-cell-lung-cancer ; translational research of the chemotherapy effect prediction factor |
Date of disclosure of the study information | 2009/01/26 |
Last modified on | 2017/05/15 |
Basic information | ||
Public title | A randomized controlled Phase II study comparing TS-1 alone with CDDP+TS-1 as postoperative adjuvant chemotherapy in non-small-cell-lung-cancer ; translational research of the chemotherapy effect prediction factor | |
Acronym | WJOG4107 | |
Scientific Title | A randomized controlled Phase II study comparing TS-1 alone with CDDP+TS-1 as postoperative adjuvant chemotherapy in non-small-cell-lung-cancer ; translational research of the chemotherapy effect prediction factor | |
Scientific Title:Acronym | WJOG4107 | |
Region |
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Condition | |||
Condition | Non Small Cell Lung Cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | YES |
Objectives | |
Narrative objectives1 | To evaluate the clinical effectiveness of TS-1 alone compared with CDDP + TS-1 for postoperative Non Small Cell Lung Cancer. Moreover, it searches for the chemotherapy effect prediction factor. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Relapse-free survival of 2 years, to searches for the chemotherapy effect prediction factor. |
Key secondary outcomes | Overall survival (OS), Rate of adverse events, Relative dose intensity, to searches for a prognosis prediction factor. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | Institution is considered as adjustment factor in dynamic allocation. |
Blocking | |
Concealment | Central registration |
Intervention | |||
No. of arms | 2 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | TS-1 | ||
Interventions/Control_2 | CDDP,TS-1 | ||
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Histologically confirmed Non Small Cell Lung Cancer
2)pStage II, IIIA (N2 Case is single station) 3)Case in which chemotherapy enforcement less than 8weeks after the operation is possible 4)Without prior chemotherapy nor use of chemotherapy, RT 5)Oral intake is possible 6)20<=,<75 years 7)Performance Status (ECOG) 0-1 8)Adequate organ functions 9)Written informed consent |
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Key exclusion criteria | 1) clinically significant drug allergy
2) Under treatment with flucytosine, phenytoin, Warfarin Potassium, other trial drugs. 3) The infection which needs the medical treatment by antibiotics, and other serious complications 4) The case which has diarrhea continuously 5) The case which has clear interstitial pneumonia or a clear fibroid lung with a chest simple X ray 6) The case which has malignant tumors other than the lung cancer 7) The case which has the past of a malignant tumor 8) Not suitable for participating in the study for any other reason |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hiroshima city hospital | ||||||
Division name | Dept of chemotherapy center | ||||||
Zip code | |||||||
Address | 7-33.Moto-machi. Naka-ku. Hiroshima.shi.730-8518 Japan | ||||||
TEL | 082-221-2291 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | West Japan Oncology Group | ||||||
Division name | WJOG datacenter | ||||||
Zip code | |||||||
Address | Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN | ||||||
TEL | 06-6633-7400 | ||||||
Homepage URL | |||||||
datacenter@wjog.jp |
Sponsor | |
Institute | West Japan Oncology Group |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | http://www.ncbi.nlm.nih.gov/pubmed/26253869 |
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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001999 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |