UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of chemoradiotherapy with use of involved-field conformal radiotherapy and accelerated hyperfractionation for Stage III non-small cell lung cancer
Acronym	A phase II study of chemoradiotherapy with IF-RT and AHF for Stage III NSCLC
Scientific Title	A phase II study of chemoradiotherapy with use of involved-field conformal radiotherapy and accelerated hyperfractionation for Stage III non-small cell lung cancer
Scientific Title:Acronym	A phase II study of chemoradiotherapy with IF-RT and AHF for Stage III NSCLC
Region	Japan

Condition
Condition	Stage III non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and the safety of chemoradiotheray with use of involved-field conformal radiotherapy and accelerated hyperfractionation for Stage III non-small cell lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Three-year survival ratio
Key secondary outcomes	Annual year survival ratio, Median survival time, Local control rate, The ratio of the patients who completed the course, Adverse events

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 Device,equipment
Interventions/Control_1	Concurrent chemotherapy(carboplatin [CBDCA] -AUC 2mg/ml min day 1, paclitaxel [PTX] -40mg/m^2 day 1)is weekly given for 4 cycles. Twice daily radiotherapy (1.5Gy/fr, total dose; 66Gy) using 3D-CRT starts on day 1, followed by 2 cycles of consolidation chemotherapy ( CBDCA-AUC 5mg/ml min day 1 plus PTX-200mg/m^2 day 1).
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	(1) Histologically or cytologically confirmed NSCLC. (2) Expected more than 90 days survival. (3) Stage IIIA, IIIB based on General Rule for Clinical and Pathological Record of Lung Cancer (The 7th Edition) without the treatment history of chemotherapy, radiotherapy and surgery (except explorative thoracotomy). (4)Unexpected complete tumor resection. (5)Expected completion of planed radiotherapy judged by a radiation oncologist, based on 3-dimentional radiotherapy planning V20 of the lung <=35% PRV of the spinal cord Dmax <=52Gy Dmax of the esophagus <=68Gy V50 of the esophagus<=50% (6) ECOG performance status 0-1 (7) Patients are >=20 years and < 75 years of age at the time of signature of the informed consent. (8) Adequate major organ function (including bone-marrow, heart, liver, renal function) as assessed by standard laboratory criteria as follows: White blood cell>=4,000/mm3 Platelet>=100,000/mm3 Hemoglobin>=9.5g/dl AST,ALT<=100IU/L Total bilirubin<=1.5 mg/dL Creatinin<=1.5mg/dL PaO2 (room air) >=70Torr (9) Written informed consent
Key exclusion criteria	(1)Chest CT shows active interstitial pneumonia or pulmonary fibrosis or severe pulmonary emphysema. (2)The patient has SVC syndrome. (3)The patient has one or more nodal metastases as listed below; supraclavicular node, anterior scalene node, contralateral hilar node. These nodes are assumed as positive if they are FDG/PET positive and have more than 5mm diameter. Malignant pleural effusion, malignant pericardial effusion and malignant lymphangitis are also ineligible. (4)The patient has a history of previous thoracic radiotherapy. (5)The patient has active previous or concomitant malignancies. (6)The patient has uncontrolled diabetes mellitus. (7) The patients has active local or systemic infection, which should be treated. (8)The patient has a severe complication (ex.gastrointestinal bleeding, heart disease, glaucoma, HIV infection). (9) The patient has a history of allergy against agents containing polyoxyethilene oil or severe drug allergy. (10) The patient has psychiatric disorders that may comprise the patient s ability to comply with the study. (11) Positive serum HBs antigen or HCV antibody. (12) The patient is pregnant, may be pregnant, or is lacting. The patient, if is of child-bearing potential, does not practice contraception. (13) In the view of the investigator, the patient can and will comply with the requirement of the protocol.
Target sample size	44

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masako Hosono
Organization	Osaka City University Hospital
Division name	Dept of Radiology
Zip code
Address	1-4-3, Asahimachi, Abenoku,
TEL	06-6645-3831
Email	mhosono@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shinichiro Nakamura
Organization	West Japan Oncology Group
Division name	datacenter
Zip code
Address	Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka
TEL	06-6633-7400
Homepage URL
Email	datacenter@wjog.jp

Sponsor
Institute	West Japan Oncology 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)

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	2013 Year 04 Month 05 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	Main results already published
Date of protocol fixation	2013 Year 03 Month 20 Day
Date of IRB	2012 Year 08 Month 27 Day
Anticipated trial start date	2013 Year 06 Month 04 Day
Last follow-up date	2018 Year 08 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 04 Month 05 Day
Last modified on	2019 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012197