UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005036 |
|---|---|
| Receipt number | R000005989 |
| Scientific Title | Pemetrexed plus radiation therapy for first-line treatment of local advanced non-small cell lung cancer (NSCLC) in 71 years old or more patients: Phase I / II study |
| Date of disclosure of the study information | 2011/02/06 |
| Last modified on | 2017/08/13 08:54:27 |
* 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
Pemetrexed plus radiation therapy for first-line treatment of local advanced non-small cell lung cancer (NSCLC) in 71 years old or more patients: Phase I / II study
Acronym
Pemetrexed + radiation therapy for elderly patients (Phase I / II study)
Scientific Title
Pemetrexed plus radiation therapy for first-line treatment of local advanced non-small cell lung cancer (NSCLC) in 71 years old or more patients: Phase I / II study
Scientific Title:Acronym
Pemetrexed + radiation therapy for elderly patients (Phase I / II study)
Region
| Japan |
Condition
Condition
local advanced non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the recommended dose of pemetrexed and safety and efficacy in treated with pemetrexed plus thoracic radiation for 71 years old or more patients with advanced non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Phase I:
recommended dose of pemetrexeds
Phase II:
response rate
Key secondary outcomes
Phase I:
progression free survival
overall survival
response rate
Phase II:
progression free survival
overall survival
safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pemetrexed + radiation therapy
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
| 71 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Local advanced stage ,Stage III
2 unable to perform surgery and able to radiation therapy, V20 < 35%
3 Histlogocally and/or cytologically proven NSCLC
4 Age: 71 years old or more
5 PS, ECOG scale: 0 to 2
6 Adequate organ function
ANC >2000/mm3,
Hb >9.0g/dl
T-Bil <1.5mg/dl
CCr >45ml/min
Cr < Normal upper limit
AST/ALT < 2.5 x Normal Upper limit
PaO2 room air > 70mmHg
7 Written informed concent
8 over 3 months life time expectancy
9 Have the assessment lesion
Key exclusion criteria
1 Double cancer
2 Severe hypertension
3 Have the anamnesis of heart failure or cardiac infarction
4 Uncontrolled diabetes
5 Do not adhibit the Vitamin B12 and follic acid
6 Have the interstitial change on chest X-ray or chest CT
7 Have the bacterial infection
8 Have the disturbance patients
9 Attending judge the patients not to enregister because of safety
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Atagi |
Organization
Kinki-Chuo Chest Medical Center
Division name
Thoracic Oncology
Zip code
Address
1180, Nagasone-cho, Kita-ku, Sakai-city, Osaka, Japan
TEL
072-252-3021
s-atagi@kch.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Tamiya |
Organization
Kinki-Chuo Chest Medical Center
Division name
Thoracic Oncology
Zip code
Address
1180, Nagasone-cho, Kita-ku, Sakai-city, Osaka, Japan
TEL
072-252-3021
Homepage URL
akihiro1252akihiro@yahoo.co.jp
Sponsor or person
Institute
Kinki-Chuo Chest Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Organization
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
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
近畿中央胸部疾患センター（大阪府）
名古屋医療センター（愛知県）、
四国がんセンター（愛媛県）、
旭川医療センター（北海道）
西群馬病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2011 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2015 | Year | 01 | 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
| 2011 | Year | 02 | Month | 06 | Day |
Last modified on
| 2017 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005989
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
