UMIN-CTR Clinical Trial

Basic information
Public title	A phase 2 study of proton therapy for inoperable stage I non-small cell lung cancer
Acronym	Proton therapy for inoperable stage I non-small cell lung cancer
Scientific Title	A phase 2 study of proton therapy for inoperable stage I non-small cell lung cancer
Scientific Title:Acronym	Proton therapy for inoperable stage I non-small cell lung cancer
Region	Japan

Condition
Condition	Stage I non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of proton therapy for stage I non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The rate of grade 3 and higher radiation pneumonitis within 180 days after the start of irradiation
Key secondary outcomes	Local control rate, overall survival period, progression-free survival period, event-free survival period, local progression-free survival period, patterns of failure, adverse event, QOL

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	Maneuver
Interventions/Control_1	Proton therapy (66 GyRBE in 10 fractions over 2 weeks or 72.6 GyRBE in 22 fractions over 4.4 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically or transbronchoscopic cytologically confirmed non-small cell lung cancer 2) Clinical stage IA or IB (7th edition of TNM staging of Union for International Cancer Control) within 28 days 3) ECOG peformance status of 0-2 4) Age>=20 5) Capable of maintaining their position during irradiation 6) Dose constraints of the organs at risk seem to be limited within range 7) No previous radiotherapy around the lesion 8) No previous chemotherapy 9) Inoperable judged by the surgeon 10) Respiratory function (<=28 days) PaO2 in room air >=60 Torr and forced expiratory volume 1.0 >=700 mL 11) Written informed consent
Key exclusion criteria	1) Pregnancy 2) Synchronous or metachronous cancer 3) Active infectious disease 4) Other severe comorbidities 5) Severe psychological disorder 6) Apparent interstitial pneumonitis or pulmonary fibrosis detectable by chest X-ray radiography 7) Judged as inappropriate to participation by investigators
Target sample size	57

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Ogino
Organization	Nagoya city University West Medical Center, Nagoya Proton Therapy Center
Division name	Radiation oncology
Zip code	462-8508
Address	1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture
TEL	052-991-8577
Email	oginogio@gmail.com

Public contact
Name of contact person	1st name Koichiro Middle name Last name Nakajima
Organization	Nagoya city University West Medical Center, Nagoya Proton Therapy Center
Division name	Radiation oncology
Zip code	462-8508
Address	1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture
TEL	052-991-8577
Homepage URL
Email	k.nakajima.ncu@gmail.com

Sponsor
Institute	Nagoya City University West Medical Center
Institute
Department

Funding Source
Organization	None
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	Clinical Study Committees of the Nagoya City Hospital
Address	1-2-23 Wakamizu, Chikusa-ku, Nagoya-city, Aichi-prefecture
Tel	052-721-7171
Email	rinsho1@higashi-hosp.jp

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	2021 Year 10 Month 01 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	33
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	No longer recruiting
Date of protocol fixation	2013 Year 06 Month 11 Day
Date of IRB	2013 Year 05 Month 17 Day
Anticipated trial start date	2013 Year 08 Month 13 Day
Last follow-up date	2022 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 09 Month 17 Day
Last modified on	2021 Year 09 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051868