UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005875 |
|---|---|
| Receipt number | R000006939 |
| Scientific Title | A phase II trial of carboplatin and TS-1 for advanced or recurrent squamous cell lung cancer with the index of Ccr score |
| Date of disclosure of the study information | 2011/06/30 |
| Last modified on | 2020/01/04 17:57:15 |
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Basic information
Public title
A phase II trial of carboplatin and TS-1 for advanced or recurrent squamous cell lung cancer with the index of Ccr score
Acronym
OULCSG-1102
Scientific Title
A phase II trial of carboplatin and TS-1 for advanced or recurrent squamous cell lung cancer with the index of Ccr score
Scientific Title:Acronym
OULCSG-1102
Region
| Japan |
Condition
Condition
Squamous cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of CBDCA + TS-1 for advanced or reccurent squamous cell lung cancer patients with the index of Ccr score
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression free survival (PFS)
PFS during maintenance therapy
Overall survival
Safety
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically confirned squamous cell lung cancer
2)Stage IIIB without any indications for radiotherapy or Stage IV
3)Measurable disease
4)No prior treatment
5)More than 20 years old
6)ECOG performance status of 0 or 1
7)Possible oral intake
8)Adequate organ functions
9)Estimated life expectancy of at least 12 weeks
10)Signed informed consent
Key exclusion criteria
1)With adjuvant chemotherapy
2)The patients who have interstitial change
3)Allergy of the medication
4)Double cancer
5)Un-controlled pleural effusion and ascites
6)Severe complications, including AMI, un-controlled angina pectoris, and un-controlled diabetes and hypertension
7)Symptomatic brain metastasis
8)Radiation therapy which has thoracic field
9)The patients who treat with flucytosine
10)Pregnancy,breast feeding or wish of future bearing
11)Other conditions not suitable for this study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kijima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3833
tkijima@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kijima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3833
Homepage URL
tkijima@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
OULCSG
Institute
Department
Personal name
Funding Source
Organization
No
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
Osaka University Clinical Research Review Committee
Address
http://www.med.osaka-u.ac.jp/pub/hp-crc/person_concerned/download.html
Tel
06-6210-8289
rinri@hp-crc.med.osaka-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
| 2011 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/internalmedicine/58/10/58_1172-18/_pdf/-char/en
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/internalmedicine/58/10/58_1172-18/_pdf/-char/en
Number of participants that the trial has enrolled
35
Results
In the 33 patients analyzed, the primary endpoint response rate was 30.3% (95% confidence interval: 15.6-48.7%), which met the threshold 15%. The disease control rate was 75.8%. The median PFS and OS were 3.5 and 11.3 months, respectively. Ten patients received maintenance S-1, and the median PFS was 5.3 months. Grade 3/4 toxicities with a frequency of more than 5% were all controllable.
Results date posted
| 2020 | Year | 01 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 05 | Month | 15 | Day |
Baseline Characteristics
Patients with stage IIIB/IV advanced squamous cell non-small cell lung cancer
Participant flow
35 patients were enrolled and 33 eligible patients received protocol treatment and were analyzed.
Adverse events
Adverse events (AEs) of grade 3 and 4 were observed in 10 patients (30.3%). During four cycles of induction chemotherapy, grade 3 and 4 hematologic AEs included thrombocytopenia (21.3%), neutropenia (12.1%), and leukopenia (10.0%), and grade 3 and 4 nonhematologic AEs included appetite loss (12.1%), nausea (6.1%), and fatigue (6.1%). Toxicity during the maintenance phase was minimal; the grade 3 and 4 hematological AEs included thrombocytopenia (10.0%), neutropenia (10.0%), and leukopenia (10.0%), and no grade 3 or 4 nonhematologic AEs were observed.
Outcome measures
Primary endpont: response rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2011 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 29 | Day |
Last modified on
| 2020 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006939
