UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II Study of Weekly Paclitaxel and Carboplatin with Concurrent Radiation Therapy in Locally Advanced Non-Small-Cell Lung Cancer. Kansai Clinical Oncology Group KCOG T-0401
Title of the study (Brief title)	Weekly Paclitaxel and Carboplatin with Concurrent Radiation Therapy in Locally Advanced Non-Small-Cell Lung Cancer.
Region	Japan

Condition
Condition	Locally Advanced Non-Small-Cell Lung Cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	efficacy and safety of weekly Paclitaxel and Carboplatin with Concurrent Radiation Therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary end point of the phase I study was to determine a recommended dosage of paclitaxel during the concurrent chemoradiotherapy part. The primary endpoint of the phase II study was the response rate. Secondary endpoints were progression free survival, overall survival, and safety.
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The phase I study was conducted to ascertain a recommended paclitaxel dosage. In the early part, chemotherapy consisted of paclitaxel (designated dosage) on days 1, 8, 15, 29, 36, and 43, and carboplatin (AUC 5 mg/mL/min) on days 1 and 29. RTx:60 Gy in 2-Gy fractions over 6 weeks
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	Unresectable Locally Advanced Non-Small-Cell Lung Cancer Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 age more than 20 years, less 75 years leucocytes more than 4,000/mm3, neutrocytes more than 2,000/mm3, platelets more than 100,000/mm3, haemoglobin more than 9.0 g/dL, serum creatinine less than 1.5 mg/dl, AST and ALT less than twice upper limit of normal, partial pressure of arterial oxygen greater than 70 mmHg, and no abnormality found from echocardiographic examination.
Key exclusion criteria	pulmonary fibrosis requiring oxygen therapy, myocardial infarction that occurred during the prior six months, liver cirrhosis, active haemorrhage of the digestive tract, mental disorder requiring treatment, diabetes mellitus in poor control, paresis of the intestine ileus, active infection, case with a history of radiation in the fields of radiation, allergy to polyoxyethylene component preparation, peripheral neuropathy, and pregnancy. Cases that a physician judged to be inadequate were also excluded.
Target sample size	40

Research contact person
Name of lead principal investigator	Motonari Fukui
Organization	Tazuke Kofukai Medical Institute Kitano Hospital
Division name	Respiratory Disease Center
Address	2-4-20 Ohgimachi, Kita-ku,Osaka
TEL	06-6312-1221
Email	mfukui@kitano-hp.or.jp

Public contact
Name of contact person	Motonari Fukui
Organization	Tazuke Kofukai Medical Institute Kitano Hospital
Division name	Respiratory Disease Center
Address	2-4-20 Ohgimachi, Kita-ku,Osaka
TEL	06-6312-1221
Homepage URL
Email	mfukui@kitano-hp.or.jp

Sponsor
Institute	Kansai Clinical Oncology Group
Institute
Department

Funding Source
Organization	Kansai Clinical Oncology Group
Organization
Division
Category of Funding Organization	Other
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	2017 Year 03 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2004 Year 12 Month 01 Day
Anticipated trial start date	2005 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 18 Day
Last modified on	2017 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030549