UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007049
Receipt number R000008140
Scientific Title Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer
Date of disclosure of the study information 2012/01/18
Last modified on 2019/04/20 14:14:09

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Basic information

Public title

Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer

Acronym

Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer(TCOG1101)

Scientific Title

Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer

Scientific Title:Acronym

Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer(TCOG1101)

Region

Japan


Condition

Condition

Advanced non-small-cell lung cancer in elderly patients

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determine the recommend dose of TS-1 plus CBDCA chemotherapy, and to investigate the efficacy and safety of the recommend dose in elderly patients with advanced non-small-cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

Phase I study: MTD, RD

Phase II study : Response rate in RD

Key secondary outcomes

Phase I study: Safety

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-1:65mg/m2(day1-14)
q3weeks

Level1
CBDCA :AUC4(day1)+
S-1:80mg/m2(day1-14)
q3weeks

Level2
CBDCA :AUC5(day1)+
S-1:80mg/m2(day1-14)
q3weeks

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

75 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients with histlogically or
cytologically confirmed non-small cell lung cancer
2)Patients with clinical stage of IIIB-IV or recurrence after operation
3)Elderly patients over 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) With ability of oral intake
8)No prior chemotherapy nor radiation therapy
9)Adequate bone marrow reserve and organ function
10)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 drug allergy
8) History of serious allergic reaction with CBDCA or other platinum-containing drug
9) History of serious allergic reaction with S-1
10) Being treated with other pyrimidine fluoride antineoplastic agents.
11) Being treated with flucytosine.
12) Any patients judged by the investigator to be unfit to participate in the study

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi KASAI

Organization

Tochigi Cancer Center

Division name

Division of Thoracic Oncology

Zip code


Address

4-9-13 Yonan Utsunomiya City Tochigi

TEL

028-658-5151

Email

tcog1101@tcog.jp


Public contact

Name of contact person

1st name
Middle name
Last name TCOG1101study affairs office

Organization

The Tokyo Cooperative Oncology Group

Division name

Clinical Study Promotion Agency

Zip code


Address

Toa-Bldg 4F 2-1-18 Hamamatsu-cho Minato-ku Toky

TEL

03-5401-5020

Homepage URL


Email

tcog1101@tcog.jp


Sponsor or person

Institute

The Tokyo Cooperative Oncology Group

Institute

Department

Personal name



Funding Source

Organization

The Tokyo Cooperative Oncology Group

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

2012 Year 01 Month 18 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

Completed

Date of protocol fixation

2011 Year 11 Month 29 Day

Date of IRB

2011 Year 07 Month 27 Day

Anticipated trial start date

2012 Year 02 Month 01 Day

Last follow-up date

2016 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2012 Year 01 Month 11 Day

Last modified on

2019 Year 04 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008140


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name