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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000896
Receipt No. 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

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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
Email

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
Email NPOTORGHKojima@aol.com

Sponsor
Institute Thoracic Oncology Research 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
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001053

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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