UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000896 |
|---|---|
| Receipt number | R000001053 |
| Scientific Title | A combination phase II study of gemcitabine and S-1 for platinum-refractory patients with non-small cell lung cancer (TORG 0705) |
| Date of disclosure of the study information | 2007/12/01 |
| Last modified on | 2010/11/15 09:22:13 |
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Basic information
Public title
A combination phase II study of gemcitabine and S-1 for platinum-refractory patients with non-small cell lung cancer (TORG 0705)
Acronym
A combination phase II study of gemcitabine and S-1 for platinum-refractory patients with non-small cell lung cancer (TORG 0705)
Scientific Title
A combination phase II study of gemcitabine and S-1 for platinum-refractory patients with non-small cell lung cancer (TORG 0705)
Scientific Title:Acronym
A combination phase II study of gemcitabine and S-1 for platinum-refractory patients with non-small cell lung cancer (TORG 0705)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical relevance of combination chemotherapy consisting of S-1 and gemcitabine for patients with relapsed and/or first-line chemotherapy resistant non-small cell lung carcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Overall response rate
Key secondary outcomes
Toxicity, Overall survival, Progression free survival, Subset analyses
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
Chemotherapy
S-1 (60 mg/m2, days 1-14, every 3 weeks)
Gemcitabine (1,000 mg/m2, days 8 and 15, every 3 weeks)
at least 3 courses, until reaching PD
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically/cytologically proven non-small cell lung cancer.
2) Prior chemotherapy of 2 or less than 2 regimens. Post-operative adjuvant chemotherapy, induction chemotherapy and intra-thoracic installation of cytotoxic agents are not considered as a regimen.
3) Prior chemotherapy consisting of platinum agents in at least one regimen.
4) Relapse after and/or resistant (SD or PR) to prior chemotherapy.
5) Interval of more than 28 days from the last chemotherapy/radiotherapy.
6) Lesions evaluated with RECIST.
7) PS (ECOG) of 0-1.
8) Preserved organ functions as
a) Hb >= 9.0 g/dL
b) Neutrophils >= 2,000/mm3
c) Platelets >= 100,000/mm3
d) AST/ALT <= 2.5 x upper limit of the normal value
e) T. Bil <= 2.0 mg/dL
f) Serum creatinine <= 1.5 mg/dL
g) Creatinine crearance >=50 ml/min
h) PaO2 >= 70 torr
9) Written informed consent.
Key exclusion criteria
1) Any contraindication for S-1 or gemcitabine.
2) Active concomitant malignancy.
3) Active infectious diseases.
4) Prior resection of primary tumor.
5) Interstitial pneumonia obviously presented by x-ray and/or clinical manifestations.
6) Experience of any pulmonary event during the previous chemotherapy.
7) Prior chemotherapy including any primidine analogue such as 5-FU, tegafur, UFT, S-1, capecitabine, gemcitabine and Ara-C.
8) Brain metastasis with symptoms or requirement of treatment.
9) Requirement of thoracic irradiation.
10) Pleural effusion, ascites or pericardial effusion requiring treatment.
11) Serious abnormalty in ECG.
12) Uncontrolled diabetes mellitus.
13) Women in regnancy, potential pregnancy, or breast feeding. Men willing to cause pregnancy.
14) Other inadequate conditions .
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takiguchi, Yuichi |
Organization
Chiba University
Division name
Department of Respirology (B2)
Zip code
Address
1-8-1, Inohana, Chuo-Ku, Chiba, Japan
TEL
043-226-2577
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kojima, Hiroyuki |
Organization
Thoracic Oncology Research Group
Division name
Secretariat office
Zip code
Address
1-45-5, Denn-Enn-Chofu, Ohta-Ku, Tokyo
TEL
03-3722-5330
Homepage URL
NPOTORGHKojima@aol.com
Sponsor or person
Institute
Thoracic Oncology Research Group
Institute
Department
Personal name
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
TORG0705
Org. issuing International ID_1
Thoracic Oncology Research Group
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Treatment was administered for median 4 courses (range 1 - 13) over a median 125-day period in 34 patients The overall response rate was 23.5% (no complete response and 8 partial response; 95% confidence interval: 9.1 - 38.0%). The median progression-free and overall survival times were 6.6 and 19.9 months, respectively. The 1- and 2-year survival rates were 58.8 and 30.9%, respectively. Toxicity was mild during the entire treatment period, except for 3 grade 3 interstitial pneumonia.
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
| 2007 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 05 | Month | 01 | Day |
Other
Other related information
ISSN: 1556-0864/10/0512-0001
Journal of Thoracic Oncology6; Volume 5, Number 12, December 2010 (in press)
Management information
Registered date
| 2007 | Year | 11 | Month | 15 | Day |
Last modified on
| 2010 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001053
