UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001928
Receipt number R000002349
Scientific Title Phase II trial of preoperatively CDDP/S-1 for patients with clinical stage II(exclusion N0 disease) and Stage IIIA non-small cell lung cancer
Date of disclosure of the study information 2009/05/01
Last modified on 2009/05/01 17:28:55

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase II trial of preoperatively CDDP/S-1 for patients with clinical stage II(exclusion N0 disease) and Stage IIIA non-small cell lung cancer

Acronym

Induction chemotherapy of CDDP/S-1 for patients with stage II or IIIA non-small cell lung cacer

Scientific Title

Phase II trial of preoperatively CDDP/S-1 for patients with clinical stage II(exclusion N0 disease) and Stage IIIA non-small cell lung cancer

Scientific Title:Acronym

Induction chemotherapy of CDDP/S-1 for patients with stage II or IIIA non-small cell lung cacer

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To investigate the efficacy of preoperative CDDP/S-1 and the relation to biomarkers for patients with II, IIIA advanced non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Analysis of regulation factors from lymph node samples usng EBUS-TBNA and relation to radiological, histological response rate after induction chemotherapy

Key secondary outcomes

feasibility, progression free survival, overall survival,and safety


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

Preoperatively induction chemotherapy
(CDDP/S-1)

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)Histlogically confirmed non-small cell lung cancer
2)In principles, resectable stage II (exculde N0 disease) and stage IIIA patients by lobectomy, histologically or cytologically diagnosed N-factor using EBUS-TBNA
3)N2 disease without extra-nodal invasion
4)>=20, <75 years of age
4)feasible oral consumption
5)Performance statas 0 or 1 cases (ECOG scale)
6)Without previous therapy (operation, rdiotherapy, chemotherapy etc.) for non^small cell lung cancer
7)preserved organ's function within 2 weeks before registration.
KL-6: normal
WBC: more than 4000/m3
Neutorocytes: more than 2000/m3
Platelet: more than 100,000/m3
Hb: 9.0 more than g/dl
AST(GOT), ALT(GPT): less than 100 IU/L
T-bil: less than 1.5 md/dL
PaO2: more than 70 Torr
Ccr: 60mL/min
[Cockcroft-Gault]
male Ccr=body weight(BW)X(140-age)/(72 X serum Cre)
female Ccr=BW X (140-age)/(72 X serum Cre)X 0.85
8)Written informed consent

Key exclusion criteria

1)Patients with severe drug allergy
2)Patients with administration of another 5-fluouracil derivative drugs, flucytosine, phenytoin, warfarin sodium
3)Patients with active concomitant malignancy
4)Patients with active severe infection, diarrhea, interstinalparalysis, ileus, uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months from onset, heart failure, other severe complications
5)Patients with active lung disease such as idopathic pulmonary fibrosis, pulmonary emphysema, severe chronic bronchitis, bronchial asthma
6)Patients with uncontrollable psychiatrical complications

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ichiro Yoshino

Organization

Graduate School of Medicine, Chiba University

Division name

Thoracic Surgery

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Graduate School of Medicine, Chiba University

Division name

Thoracic Surgery

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Thoracic Surgery, Graduate School of Medicine, Chiba University

Institute

Department

Personal name



Funding Source

Organization

Thoracic Surgery, Graduate School of Medicine, Chiba University

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

2009 Year 05 Month 01 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

Date of protocol fixation

2008 Year 12 Month 12 Day

Date of IRB


Anticipated trial start date

2008 Year 12 Month 01 Day

Last follow-up date

2015 Year 10 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

2009 Year 05 Month 01 Day

Last modified on

2009 Year 05 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002349


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name