UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014330 |
|---|---|
| Receipt number | R000016682 |
| Scientific Title | A Phase I Study of Pemetrexed, Carboplatin, and Radiation Therapy in Locally Advanced Non-Squamous-Cell, Non-Small-Cell Lung Cancer |
| Date of disclosure of the study information | 2014/06/23 |
| Last modified on | 2017/07/10 15:39:36 |
* 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
A Phase I Study of Pemetrexed, Carboplatin, and Radiation Therapy
in Locally Advanced Non-Squamous-Cell, Non-Small-Cell Lung Cancer
Acronym
PRINCE
Scientific Title
A Phase I Study of Pemetrexed, Carboplatin, and Radiation Therapy
in Locally Advanced Non-Squamous-Cell, Non-Small-Cell Lung Cancer
Scientific Title:Acronym
PRINCE
Region
| Japan |
Condition
Condition
elderly patients with localy advanced non-small-cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the maximum-tolerated dose (MTD) and the recommended dose (RD) of radiation and CBDCA+Pemetrexed
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
To determine the maximum-tolerated dose (MTD)
Key secondary outcomes
ORR, PFS, OS
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
CBCDA: AUC4-5, weekly
PEM:500mg/m2, weekly
concurrent TRT: 2Gy/day todal 60Gy
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) Histologically or cytologically confirmed non-sqamous non-small-cell lung cancer with Chemo-naive patients
2) Stage III, without indication for curative resection, with irradiation
3) Patients aged 75- years
4) ECOG performance status 0-1
5) Adequate organ function
6) Excepted to live over 3 months after administration day
7) Written informed consent from the patients
Key exclusion criteria
1) squamous cell carcinoma
2) Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray
3) Pleural effusion, pericardial effusion and ascites to need treatment
4) Severe renal function disorder
5) SVC syndrome
6) Brain metastases with neurological symptoms
7) Active double cancer
8) Uncontrollable diabetes mellitus and hypertenson
9) Liver cirrhosis by image findings or laboratory examinations
10) History of severe heart disease (myocardial infarction within 6 months, unstable angina, post-PTCA or CAGB, signs of congestive heart failue, arrythmia with past history of heart failure, etc.)
11) Pregnancy, breast feeding and suspected pregnancy
12) History of grave drug allergic reaction
13) Acute inflammatory disease
14) An agreement is not obtained for support therapy such as transfusion etc
15) Having the bleeding tendency which is clinically apparent
16) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoya Kawaguchi |
Organization
Osaka City University Hospital
Division name
Chemotherapy center
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3793
y-naruo@sc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naruo Yoshimura |
Organization
Osaka City University Hospital
Division name
Chemotherapy center
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3793
Homepage URL
y-naruo@sc4.so-net.ne.jp
Sponsor or person
Institute
Osaka Lung Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2014 | Year | 06 | Month | 23 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 20 | Day |
Last modified on
| 2017 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016682
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
