UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009760 |
|---|---|
| Receipt number | R000011435 |
| Scientific Title | Phase I study of TS-1 and Nedaplatin for previously untreated patients with advanced squamous cell carcionoma of lung |
| Date of disclosure of the study information | 2013/01/11 |
| Last modified on | 2013/01/11 19:34:18 |
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Basic information
Public title
Phase I study of TS-1 and Nedaplatin for previously untreated patients with advanced squamous cell carcionoma of lung
Acronym
Phase I study of TS-1 and CDGP for sq. cell carcioma of lung
Scientific Title
Phase I study of TS-1 and Nedaplatin for previously untreated patients with advanced squamous cell carcionoma of lung
Scientific Title:Acronym
Phase I study of TS-1 and CDGP for sq. cell carcioma of lung
Region
| Japan |
Condition
Condition
Squamous cell carcinoma of lung
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the maximum tolerated dose and the recommended dose of TS-1 and Nedaplatin for previously untreated advanced squamous cell carcinoma of lung
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Maximum tolerated dose (MTD) of TS-1 and Nedaplatin
Key secondary outcomes
response rate
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
TS-1 is administered at fixed doses based on the body surface area (BSA) of the patient (BSA<1.25 m2 80mg/day; BSA 1.25-1.5 m2 100mg/day; BSA>1.5 m2 120mg/day) on day 1-14 q3w.
Nedaplatin is administered at a dose of allocated level q3w.
Level 1 60 mg/m2
Level 2 70 mg/m2
Level 3 80 mg/m2
Level 4 90 mg/m2
Level 5 100 mg/m2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Previously untreated patients with histologically or cytologically proven squamous carcinoma of lung (include post surgical recurrence)
2.With one or more measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST)
3.No indication of radical radiotherapy, Stage IIIB or IV
4.Age over 18
5.Performance Status (ECOG): 0 to 1
6.Adequate major organ functions
WBC>=3,000/uL
Neutro>=2,000/uL
Hgb>=9.5 g/dL
Platelets>=100,000/uL
AST <=100 IU
ALT <=100 IU
T-Bil <=1.5 mg/dL
eGFR >=60
PaO2 >=60 torr or SpO2 >=90%
7.A life expectancy of more than three months
8.Written informed consent
Key exclusion criteria
1.Interstitial pneumonia or pulmonary fibrosis detectable on chest radiograph.
2.Massive pericardial, pleural effusion or ascites
3.SVC syndrome
4.Symptomatic brain metastasis
5.Active concomitant malignancy
6.Uncontrollable diabetes mellitus or hypertension
7.Liver cirrhosis
8.Myocardial infarction within 6 months, unstable angina, those who received PTCA or CAGB within 6 months, congestive heart failure, uncontrollable arrhythmia
9.Pregnant or lactating women or those who declined contraception.
10.Severe drug allergy
11.Acute inflammatory diseases
12.Refusal against blood transfusion or other supportive therapies
13.Evidence of bleeding diathesis
14.Active infection
15.Those judged to be not suitable by the attending physician
16.Planning of thoracic radiotherapy during the trial.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Misato Okamura |
Organization
National Hospital Organization, Kyoto Medical Center
Division name
Pulmonary Medicine
Zip code
Address
1-1 Mukaihata, Fushimi-ku, Kyoto City, Japan
TEL
075-641-9161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Misato Okamura |
Organization
National Hospital Organization, Kyoto Medical Center
Division name
Pulmonary Medicine
Zip code
Address
1-1 Mukaihata, Fushimi-ku, Kyoto City, Japan
TEL
075-641-9161
Homepage URL
Sponsor or person
Institute
Pulmonary Medicine, NHO Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Pulmonary Medicine, NHO Kyoto Medical Center
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
独立行政法人国立病院機構京都医療センター
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 11 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 11 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 15 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 11 | Day |
Last modified on
| 2013 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011435
