UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002586
Receipt No. R000003105
Scientific Title Phase I study of Pemetrexed/CDGP for advanced and relapsed NSCLC after thoracic surgery
Date of disclosure of the study information 2009/11/01
Last modified on 2011/10/25

* 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 I study of Pemetrexed/CDGP for advanced and relapsed NSCLC after thoracic surgery
Acronym Phase I study of Pemetrexed/CDGP chemptherapy
Scientific Title Phase I study of Pemetrexed/CDGP for advanced and relapsed NSCLC after thoracic surgery
Scientific Title:Acronym Phase I study of Pemetrexed/CDGP chemptherapy
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and feasibility of ALIMTA/CDGP combined chemotherapy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To determine the recommended dose of ALIMTA/CDGP combined chemotherapy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 chemotherapy
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 Patients with histologically or cytologically confirmed NSCLC, who had not previously received any chemotherapy or radiotherapy, and relased after thoracic surgery. Other criteria included: 1) age >20 and <75 years; 2) Eastern Clinical Oncology Group (ECOG) performance status 0&#8211;1; 3) unresectable stage IIIb or IV disease; 4) adequate bone marrow function (neutrophil count >2 x 103/&micro;l, hemoglobin 10 g/dl, platelet count > 10 x 10 4/&micro;l), normal hepatic function (total bilirubin level < 1.5 mg/dl and AST < twice the upper normal limit), and renal function (serum creatinine <1.2 mg/dl, creatinine clearance > 60 ml/min). PO2 >60 torr.
Key exclusion criteria 1) interstitial pneumonia on chest XP, 2) pleural or pericardial effusion that required drainage, 3)neuropathy grade over 2, 4) systemic edema grade over 2, 5) severe heart disease, hypertension, DM, 6) active infection 7) active brain metastasis, or 8) pregnancy. 9) double cancers, 10) past history of hypersensitivity to drugs,
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Yoshida
Organization Shinshu University
Division name Departmant of Surgery, Respiratory Division
Zip code
Address 3-1-1 Asahi Matsumoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Shinshu University
Division name Respiratory Division
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Other
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 11 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 No longer recruiting
Date of protocol fixation
2009 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2011 Year 09 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 10 Month 05 Day
Last modified on
2011 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003105

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.