UMIN-CTR Clinical Trial

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

Non-small cell lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Faculty of Medicine, Kagawa University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

04

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

04

Month

05

Day

Last modified on

2011

Year

04

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006390