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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005380
Receipt No. R000006390
Scientific Title Phase1/2 study of Radiation and S-1 and Carboplatin concurrent induction therapy for locally advanced non-small cell Lung cancer(RASCAL Study)
Date of disclosure of the study information 2011/04/10
Last modified on 2011/04/05

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Basic information
Public title Phase1/2 study of Radiation and S-1 and Carboplatin concurrent induction therapy for locally advanced non-small cell Lung cancer(RASCAL Study)
Acronym Phase1/2 study of Radiation and S-1 and Carboplatin concurrent induction therapy for locally advanced non-small cell Lung cancer(RASCAL Study)
Scientific Title Phase1/2 study of Radiation and S-1 and Carboplatin concurrent induction therapy for locally advanced non-small cell Lung cancer(RASCAL Study)
Scientific Title:Acronym Phase1/2 study of Radiation and S-1 and Carboplatin concurrent induction therapy for locally advanced non-small cell Lung cancer(RASCAL Study)
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of induction chemoradiotherapy of Carboplatin+S-1+RT
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I
Maximum tolerated dose
Recommended dose
Phase II
Response Rate
Key secondary outcomes Phase I
Safety, Response rate, Phathologic response
Phase II
Safety, 3 year survival rate, Phathlogic response

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 Induction chemoradiotherapy
TS-1+CBDCA+RT
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 or cytologically confirmed non-small-cell lung cancer
2) Stage 2(except N0) or stage 3
3)No previous therapy
4)Performance status was 0 to 2

5)No distant metastasis were revealed by FDG-PET (chest CT, abdominal CT, brain CT, MRI, bone scan)
6)Adequate function of vital organs, including normal hematopoietic function, normal liver function, normal renal function and normal lung function as evidenced by the following data:
1:WBC >= 4,000/mm3, < 12,000/mm3
2:Neu >= 1,500/ mm3
3:Plt >= 100,000/ mm3
4:Hb >= 9.0g/dl
5:T-Bil < 1.5mg/dL
6:AST and ALT, x 2.5 of upper limit of normal (ULN) or less
7:creatinine clearance>=60ml/min
8:PaO2 >= 60 torr or SpO2 >= 90%
7) Normal Cardiac function
8)Written informed consent by the patient
Key exclusion criteria 1)Patient who is not candidates for Carboplatin or TS-1
2)Patient with Anamnesis of drug allergy
3)Patient with Myocardial infarction within the past 6 months
4)Patient with Clinically active interstitial pneumonia or pulmonary fibrosis, detectable on CT scan
5)Patient with serious heart disease

6)Patient with psychiatric disorder

7)Patient with uncontrollable diabetes
8)Patient with paresis of intestine, intestinal obstruction
9) Patient with the diarrhea
10)Patients with active severe infections
11) Patients with active concomitant malignancy
12)Patient with Active concomitant malignancy
13)Women during pregnancy or lactating
14) Refusal of contraception
15) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shintaro Tarumi
Organization Faculty of Medicine, Kagawa University
Division name Departments of General Thoracic Surgery, Breast and Endocrinological Surgery
Zip code
Address 1750-1 Miki-cho, Kita-gun, Kagawa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Faculty of Medicine, Kagawa University
Division name Departments of General Thoracic Surgery, Breast and Endocrinological Surgery
Zip code
Address 1750-1 Miki-cho, Kita-gun, Kagawa
TEL
Homepage URL
Email

Sponsor
Institute Faculty of Medicine, Kagawa University
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 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 04 Month 10 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 Preinitiation
Date of protocol fixation
2011 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2016 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 04 Month 05 Day
Last modified on
2011 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006390

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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