UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011663
Receipt number R000011565
Scientific Title Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in patients with unresectable locally advanced non-small cell lung cancer
Date of disclosure of the study information 2013/09/05
Last modified on 2013/09/06 12:44:31

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Basic information

Public title

Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in patients with unresectable locally advanced non-small cell lung cancer

Acronym

Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in patients with unresectable locally advanced non-small cell lung cancer

Scientific Title

Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in patients with unresectable locally advanced non-small cell lung cancer

Scientific Title:Acronym

Phase I/II trial of carboplatin, TS-1, and concurrent radiation therapy in patients with unresectable locally advanced non-small cell lung cancer

Region

Japan


Condition

Condition

Unresectable locally advanced non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determine recommended dose, efficacy, and safety of carboplatin, TS-1, and concurrent radiation therapy in patients with locally advanced non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Phase I study: MTD, RD

Phase II study : Response rate in RD

Key secondary outcomes

Phase I study: Safety, RR

Phase II study : OS, PFS 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

Level0
CBDCA :AUC4(day1)+
S-1:50mg/m2(day1-14)+
RT 2Gy * 5days/week (total: 60Gy)
q4weeks
Level1
CBDCA :AUC5(day1)+
S-1:50mg/m2(day1-14)+
RT 2Gy * 5days/week (total: 60Gy)
q4weeks
Level2
CBDCA :AUC5(day1)+ S-1:65mg/m2(day1-14)
RT 2Gy * 5days/week (total: 60Gy)
q4weeks
Level3
CBDCA :AUC5(day1)+
S-1:80mg/m2(day1-14)
RT 2Gy * 5days/week (total: 60Gy)
q4weeks

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)Patients with clinical unresectable stage IIIA or IIIB
3) 20<=, <75 years old
4)ECOG Performance status 0-1
5) Expected survival more than 3 months
6)A measurable lesion according to the Response Evaluation Criteria in Solid Tumors
7)No prior chemotherapy nor radiation therapy
8)Adequate bone marrow reserve and organ function
9)Written IC

Key exclusion criteria

1)Patients with interstitial pneumonia or pulmonary fibrosis on Chest X-ray
2)Patients with pleural or pericardial effusion ,or ascites
3) Patients with active double cancer
4)Patients with significant complications
a) Uncontrolled angina pectoris, myocardial infarction, heart failure within 3 months
b)Uncontrolled diabetes or hypertension
c)Current severe infection, or suspicious of severe infection
d) Patients whose participation in the trial is judged to be inappropriate by the attending doctor. (e.g., ileus, bleeding tendency, diarrhea and varicella)
5)Patients with symptomatic brain metastasis
6)Patients with pregnancy or lactation
7) History of serious allergic reaction with CBDCA or other platinum-containing drug
8) History of serious allergic reaction with S-1
9) Being treated with other pyrimidine fluoride antineoplastic agents.
10) Being treated with flucytosine.
11) Any patients judged by the investigator to be unfit to participate in the study

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiki Ishii

Organization

Dokkyo Medical University

Division name

Department of Pulmonary Medicine and Clinical Immunology

Zip code


Address

880 Kitakobayashi, Mibu, Tochigi, Japan

TEL

0282-87-2151

Email

ishiiysk@dokkyomed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshiki Ishii

Organization

Dokkyo Medical University

Division name

Department of Pulmonary Medicine and Clinical Immunology

Zip code


Address

880 Kitakobayashi, Mibu, Tochigi, Japan

TEL

0282-87-2151

Homepage URL


Email

ishiiysk@dokkyomed.ac.jp


Sponsor or person

Institute

Dokkyo Medical University

Institute

Department

Personal name



Funding Source

Organization

Dokkyo Medical 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

2013 Year 09 Month 05 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 09 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 05 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 05 Day

Last modified on

2013 Year 09 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011565


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name