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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034543
Receipt No. R000039380
Scientific Title Phase I Dose-Escalation Study of Accelerated Hyperfractionation and Intensity-modulated Radiation Therapy in Patients with Locally Advanced Non Small Cell Lung Cancer
Date of disclosure of the study information 2018/11/01
Last modified on 2018/10/17

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Basic information
Public title Phase I Dose-Escalation Study of Accelerated Hyperfractionation and Intensity-modulated Radiation Therapy in Patients with Locally Advanced Non Small Cell Lung Cancer
Acronym Phase I Dose-Escalation Study of AHF and IMRT in Patients with Locally Advanced NSCLC
Scientific Title Phase I Dose-Escalation Study of Accelerated Hyperfractionation and Intensity-modulated Radiation Therapy in Patients with Locally Advanced Non Small Cell Lung Cancer
Scientific Title:Acronym Phase I Dose-Escalation Study of AHF and IMRT in Patients with Locally Advanced NSCLC
Region
Japan

Condition
Condition Non-small cell lung carcinoma (NSCLC)
Classification by specialty
Pneumology Hematology and clinical oncology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To estimate the maximum tolerated dose and to determine the recommended dose of accelerated hyperfractionation and intensity-modulated radiation therapy for locally advanced NSCLC
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes incidence of Grade 3 or more acute adverse events within 90 days after chemoradiotherapy
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 Chemoradiotherapy consists of CBDCA (AUC2, day 1, 8, 15, 22), PTX (40 mg/m2, day 1, 8, 15, 22) and AHF and IMRT (56-72 Gy/40 fr:56 Gy/40 fr at level 0, 60 Gy at level 1, 64 Gy at level 2, 68 Gy at level 3 and 72 Gy at level 4)
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
90 years-old >
Gender Male and Female
Key inclusion criteria 1) Histologically proven NSCLC
2) Clinical stage IIIA or IIIB Locally Advanced NSCLC
3) Aged 20 to 90 years old, ECOG Performance status 0 or 1
4) Without previous chemotherapy for primary illness
5) Without previous radiotherpy for chest
6) Adequate organ functions
7) Written informed consent
Key exclusion criteria 1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy
2) Active infection requiring systemic therapy
3) With severe complications
4) History of serious drug allegies
5) Patients with unstable and uncontrollable diabetic mellitus, hypertension, kidney disease, liver disease.
6) Patients with intersitial pneumonia or pulmonary fibrosis detectable on chest radiography
7) Women during pregnancy or breast-feeding, or patients who wish pregnancy
8) Patients that physicians consider inappropriate for this study
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukinori Matsuo
Organization Graduate School of Medicine, Kyoto University
Division name Department of Radiation Oncology and Image-applied Therapy
Zip code
Address 54 Shogoin Kawaharacho Sakyo-ku, Kyoto
TEL 0757513762
Email ymatsuo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takamasa Mitsuyoshi
Organization Graduate School of Medicine, Kyoto University
Division name Department of Radiation Oncology and Image-applied Therapy
Zip code
Address 54 Shogoin Kawaharacho Sakyo-ku, Kyoto
TEL 075-751-3762
Homepage URL
Email mitsu.t@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University
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
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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2018 Year 11 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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 17 Day
Last modified on
2018 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039380

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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