UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase I Study of Pemetrexed, Carboplatin, and Radiation Therapy in Locally Advanced Non-Squamous-Cell, Non-Small-Cell Lung Cancer
Title of the study (Brief title)	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	Tomoya Kawaguchi
Organization	Osaka City University Hospital
Division name	Chemotherapy center
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL	06-6645-3793
Email	y-naruo@sc4.so-net.ne.jp

Public contact
Name of contact person	Naruo Yoshimura
Organization	Osaka City University Hospital
Division name	Chemotherapy center
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL	06-6645-3793
Homepage URL
Email	y-naruo@sc4.so-net.ne.jp

Sponsor
Institute	Osaka Lung Cancer Study Group
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016682