UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012455
Receipt number R000014575
Scientific Title Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer
Date of disclosure of the study information 2013/12/02
Last modified on 2013/12/02 06:56:45

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Basic information

Public title

Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer

Acronym

Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer

Scientific Title

Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer

Scientific Title:Acronym

Phase II trial of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer

Region

Japan


Condition

Condition

non-small cell lung cancer

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

evaluate the efficacy and safety of cisplatin and TS-1 with radiotherapy for patients with locally advanced N2 non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

2 years survival rate

Key secondary outcomes

Response rate, Progression-free survival, Overall survival, Surgery transition rate, Rate and incidence of adverse events


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 Device,equipment

Interventions/Control_1

S-1:80mg/m2 (d1-d15)
q4w x 4 cycles
CDDP:60 mg/m2(d1)
q4w x 4 cycles
RT: 66 Gy/33frs

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

20 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Patients with histlogically or cytologically confirmed non-small cell lung cancer
2) Prior treatment of radiotherapy, chemotherapy or surgery for Patients with stage IIIA or IIIB
3)Prior treatment of chemoradiotherapy or chemotherapy for non-small cell lung cancer patients for up to 1 regimen in the EGFR-TKI untreated
4) Unresectable lung cancer
5) 20<=, <80years old
6)PS:0-1 (ECOG)
7)adequate bone marrow,liver,and renal functions
WBC count >= 4,000/mm3,
Neutrophil counts >= 2,000/mm3
Platelets >= 100,000/mm3
Hemoglobin concentration >= 9.0g/dL
Total bilirubin <= 1.5mg/dL
AST and ALT >=100IU/L
SpO2(Room air) >=90%
Creatinine clearance >= 60 mL/min,
8)written informed consent

Key exclusion criteria

1) SVC syndrome
2)Active infection more than and equal to grade 2
3) Continuous watery diarrhea
4) Significant comorbid disease such as paresis of intestine, ileus, interstitial pneumonia, lung fibrosis, uncontrolled diabetes mellitus, cardiac failure, renal failure, hepatic failure, active gastrointestinal ulcer, myocardial infarction and angina pectoris within 6 months, other uncontrolled disease
5) Continuous administration of a steroid
6) Active concomitant malignancy except carcinoma in situ, intramucosal carcinoma or cancer with more than 5 year disease free
7) Pregnant status or lactation
8) Uncontrolled psychiatric disease 9) Patients required for continuing steroid therapy
10) Severe drug allergy
11) Being treated with flucytosine.
12)Participation in other registration trial before randomization in this trial
13) Any patients judged by the investigator to be unfit to participate in the study


Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshinari Ema

Organization

Itabashi central medical center

Division name

Department of Thoracic Surgery

Zip code


Address

2-12-7 Azusawa, Itabashi, Tokyo 174-0051

TEL

03-3967-0572

Email

toshinariema09@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshinari Ema

Organization

Itabashi central medical center

Division name

Department of Thoracic Surgery

Zip code


Address

2-12-7 Azusawa, Itabashi, Tokyo 174-0051

TEL

03-3967-0572

Homepage URL


Email

toshinariema09@yahoo.co.jp


Sponsor or person

Institute

Itabashi central medical center

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


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

2013 Year 12 Month 02 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

2013 Year 12 Month 02 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 02 Day

Last follow-up date

2016 Year 11 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

2013 Year 12 Month 02 Day

Last modified on

2013 Year 12 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014575


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name