UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010396 |
|---|---|
| Receipt number | R000012144 |
| Scientific Title | WJOG7512L:A randomized phase III study of maintenance therapy with TS-1 plus best supportive care versus best supportive care after induction therapy with carboplatin plus TS-1 for advanced or relapsed squamous cell carcinoma of the lung |
| Date of disclosure of the study information | 2013/04/02 |
| Last modified on | 2021/04/15 11:53:40 |
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Basic information
Public title
WJOG7512L:A randomized phase III study of maintenance therapy with TS-1 plus best supportive care versus best supportive care after induction therapy with carboplatin plus TS-1 for advanced or relapsed squamous cell carcinoma of the lung
Acronym
A randomized phase III study of maintenance therapy with TS-1 plus best supportive care versus best supportive care after induction therapy with carboplatin plus TS-1 for advanced or relapsed squamous cell carcinoma of the lung (WJOG7512L)
Scientific Title
WJOG7512L:A randomized phase III study of maintenance therapy with TS-1 plus best supportive care versus best supportive care after induction therapy with carboplatin plus TS-1 for advanced or relapsed squamous cell carcinoma of the lung
Scientific Title:Acronym
A randomized phase III study of maintenance therapy with TS-1 plus best supportive care versus best supportive care after induction therapy with carboplatin plus TS-1 for advanced or relapsed squamous cell carcinoma of the lung (WJOG7512L)
Region
| Japan |
Condition
Condition
Advanced or relapsed squamous cell carcinoma of the lung
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of maintenance therapy with TS-1 after induction therapy with carboplatin plus TS-1 in patients with advanced or relapsed squamous cell carcinoma of the lung
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Progression free survival from the date of randomization for maintenance therapy
Key secondary outcomes
Overall survival, QOL and adverse events from the date of randomization for maintenance therapy, Progression free survival and overall survival from the date of enrollment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
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
| Medicine |
Interventions/Control_1
TS-1 after induction therapy with carboplatin plus TS-1
Interventions/Control_2
Best supportive care after induction therapy with carboplatin plus 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Induction therapy
1) Cytologically or histologically documented squamous cell carcinoma of the lung. Non-small-cell lung cancer with a predominant squamous component or adenosquamous carcinoma with a predominant squamous component is also acceptable.
2) Clinical stage IIIB, IV or postoperative recurrence, and unsuitable for radiotherapy.
3) Patient must have received no prior chemotherapy. Adjuvant chemotherapy permitted providing cytotoxic chemotherapy was completed 6 months prior to recurrence of the disease.
4) The case can eat.
5) Have measurable lesion
6) Must be 20 or more years old at the time of consent.
7) Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0~1
8) Have adequate organ function within two week before study entry
9) Estimated life expectancy of at least 12 weeks
10) Have signed an informed consent document
Maintenance therapy
Meet eligibility criteria between day15 and day43 (day 1 is the date when patients receive last dose of induction therapy)
1) Documented evidence of NOT PD at CT scan conducted during cycle4 of induction therapy
2) Have ECOG PS 0~1 at the time of randomization
3) Have adequate organ function within 1 weeks before randomization
Key exclusion criteria
Induction therapy
1) SVC syndrome
2) Clinically significant drug allergy
3) Pleural effusion, cardiac effusion, or cardiac effusion necessitating treatment
4) Have received radiation therapy or surgery to lesions of lung
5) Patient received palliative radiotherapy except to the primary lesion in last 2 weeks.
6) With severe infection, bleeding, cardiac diseases.
7) With continues diarrhea
8) Ileus or sub-ileus
9) With interstitial pneumonia, sever COPD
10) Symptomatic brain metastasis
11) Presence of other active malignancy
12) Un-controlled DM
13) Uncontrolled psychiatric disease.
14) pregnancy or lactating patients
15) Positive serum HBs antigen
16) Others
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaoru Tanaka |
Organization
Kinki University School of Medicine
Division name
Department of Medical Oncology
Zip code
Address
377-2 Ohno-higashi, Osaka-Sayama, Osaka
TEL
072-366-0221
tanaka_k@dotd.med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Nakamura |
Organization
West Japan Oncology Group
Division name
datacenter
Zip code
Address
Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
TAIHO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2013 | Year | 04 | Month | 02 | 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 | 03 | Month | 20 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | 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 | 04 | Month | 02 | Day |
Last modified on
| 2021 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012144
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