UMIN-CTR Clinical Trial

Public title

A Phase II first-line study of Carboplatin plus Pemetrexed in elderly patients with advanced non-small, non-squamous cell lung cancer

Acronym

A Phase II first-line study of CBDCA plus PEM in elderly patients with advanced non-small, non-squamous cell lung cancer

Scientific Title

A Phase II first-line study of Carboplatin plus Pemetrexed in elderly patients with advanced non-small, non-squamous cell lung cancer

Scientific Title:Acronym

A Phase II first-line study of CBDCA plus PEM in elderly patients with advanced non-small, non-squamous cell lung cancer

Region

Japan

Condition

Non-Small, Non-Squamous Cell Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Objective of the study is to investigate efficacy and safety of carboplatin plus pemetexed for elderly patients with untreated non-small, non-squamous cell lung cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

response rate

Key secondary outcomes

disease control rate, progression free survival, 1 year survival, safety, quality of life

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

combined chemotherapy with carboplatin plus pemetrexed

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

Age-lower limit

70

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically proven non-small, non-squamous cell carcinoma.
2) Stage IIIb /IV patients with no prior chemotherapy and relapsed patients who previously received surgery. Relapsed patients after surgery who previously received only oral anti-tumor drug (excluding epidermal growth factor receptor tyrosine kinase inhibitor) as post operative adjuvant therapy. Palliative radiotherapy against tumors, which are not measurable lesions, is acceptable.
3) Patients aged 70 years or older.
4) Performance status (ECOG) 0-1
5) Sufficient function of main organ and bone marrow filled the following criteria:
Leukocyte counts, 3,000/mm3 or over.
Neutrophil counts, 1,500/mm3 or over.
Platelets, 100,000/mm3 or over.
Hemoglobin, 9.0 g/dl or over.
AST and ALT, x 2 of upper limit of normal (ULN) or less.
Total bilirubin, 1.5mg/dl or less.
Serum creatinin, x 1.5 of ULN or less.
No serious arrhythmia.
PaO2 60 Torr or above, or SpO2 90% or above.
No evident interstitial pneumonia
6) Patients who has at least one or more measurable lesion(s) by RECIST.
7) Patients who are considered to survive for more than 3 months.
8) Patients providing written informed consent.

Key exclusion criteria

1) Squamous cell carcinoma
2) Cases with previous radiation therapy against primary tumor
3) Patients with superior vena cava (SVC) syndrome
4) Patients with severe drug allergy
5) Patients with massive and/or uncontrollable pleural effusion
6) Patients with massive ascites, or pericardial effusion
7) Patients with active severe infections
8) Patients with active lung disease such as interstitial pneumonia or lung fibrosis
9) Patients with symptomatic brain metastasis
10) Patients with active concomitant malignancy
11) Patients with uncontrollable complications such as psychiatric problems
12) Inappropriate patients for this study judged by the physicians

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	Akihito Yokoyama

Organization

Kochi University, School of Medicine

Division name

Department of Hematology and Respiratory Medicine

Zip code

Address

Kohasu, Okocho, Nankoku city, Kochi 783-8505, Japan

TEL

088-880-2345

Email

im62@kochi-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Tetsuya Kubota

Organization

Kochi University, School of Medicine

Division name

Department of Hematology and Respiratory Medicine

Zip code

Address

Kohasu, Okocho, Nankoku city, Kochi 783-8505, Japan

TEL

088-880-2345

Homepage URL

Email

im62@kochi-u.ac.jp

Institute

Kochi University, School of Medicine, Department of Hematology and Resporatory Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

高知大学医学部付属病院（高知県）、高知医療センター（高知県）、国立病院機構高知病院（高知県）、高知赤十字病院（高知県）

Date of disclosure of the study information

2010

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2010

Year

11

Month

25

Day

Date of IRB

Anticipated trial start date

2010

Year

12

Month

01

Day

Last follow-up date

2015

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

11

Month

30

Day

Last modified on

2014

Year

04

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005460