UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008490
Receipt number R000009981
Scientific Title Phase II study of S-1 monotherapy as 1st line chemotherapy in patients > or = 80 with advanced non-small cell lung cancer
Date of disclosure of the study information 2012/08/01
Last modified on 2012/07/21 17:58:58

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Basic information

Public title

Phase II study of S-1 monotherapy as 1st line chemotherapy in patients > or = 80 with advanced non-small cell lung cancer

Acronym

Phase II study of S-1 monotherapy as 1st line chemotherapy in patients > or = 80 with advanced non-small cell lung cancer

Scientific Title

Phase II study of S-1 monotherapy as 1st line chemotherapy in patients > or = 80 with advanced non-small cell lung cancer

Scientific Title:Acronym

Phase II study of S-1 monotherapy as 1st line chemotherapy in patients > or = 80 with advanced non-small cell lung cancer

Region

Japan


Condition

Condition

patients > or = 80 with advanced non-small cell lung cancer

Classification by specialty

Medicine in general Pneumology Surgery in general
Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and toxicity of S-1 monotherapy as 1st line chemotherapy in patients > or = 80 with advanced non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Disease-control rate

Key secondary outcomes

Overall survival Progression free survival 1 year survival rate Response rate Time to treatment failure Safety Quality of life


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

S-1 (40-60 mg/body twice per day) on days 1 to 14 of a 21-day cycle until progressive disease.

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

80 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histological or cytological proven non-small cell lung cancer
2) Locally advanced, metastatic or recurrent non-small cell lung cancer (clinical stage 3A, 3B or 4, according to TNM classification ver 7 for which curative radiotherapy is not indicated.
3) With measurable lesions by RECIST.
4) No prior chemotherapy except EGFR-TKI. Patients who experienced recurrence more than 180 days after completion of postoperative adjuvant chemotherapy with tegafur-uracil capsules/granules (UFT) will be eligible
5) Age of 80 years or older
6) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
7) Life expectancy is more than 12 weeks
8) Adequate organ function shown in physical examinations within 7 days before the registration, as defined below: Neutrophil =>1500/mm3 Platelet count =>100000/mm3 Hemoglobin =>9.0g/dL
AST ALT <= 3 x ULN Total bilirubin <=1.5mg/dL Creatinine <=1.5mg/dL
Creatinine clearance =>40mL/min
SpO2 =>90%
9) Ability to take drugs orally
10) Written informed consent

Key exclusion criteria

1) History of severe hypersensitivity drug reaction
2) Prior radiotherapy to the primary tumor except the radiotherapy to the bone metastasis and the brain metastasis.
3) Patients with administration contraindication to S-1
4) Synchronous cancer, or metachronous cancer with less than 5 years of disease-free interval except carcinoma in situ of the cervix and basal type skin cancer
5) Concomitant active infection
6) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis
7) Severe complication(s), e.g., renal failure, hepatic failure, poorly controlled diabetes, or poorly controlled hypertension
8) Distinctly abnormal ECG or cardiovascular disease (heart failure, myocardial infarction, angina)
9) Patients with severe diarrhea
10) Pleural and peritoneal likely to require surgical intervention
11) Symptomatic brain metastasis.
12) Concomitant treatment with flucytosine, phenytoin or warfarin
13) Physician concludes that the patient's participation in this trial is inappropriate

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomonobu Koizumi

Organization

Shinshu University Hospital

Division name

Comprehensive Cancer Center

Zip code


Address

3-1-1, Asahi, Matsumoto-shi, Nagano-ken, 390-8621, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Shinshu University School of Medicine

Division name

the Comittee for Medical Ethics

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Shinshu University Hospital

Institute

Department

Personal name



Funding Source

Organization

Shinshu University School of Medicine

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 08 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

Open public recruiting

Date of protocol fixation

2012 Year 04 Month 26 Day

Date of IRB


Anticipated trial start date

2012 Year 05 Month 01 Day

Last follow-up date

2016 Year 04 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

2012 Year 07 Month 21 Day

Last modified on

2012 Year 07 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009981


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name