UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034543 |
|---|---|
| Receipt number | 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 | 2023/10/21 10:29:20 |
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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 | Noriko |
| Middle name | |
| Last name | Kishi |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Radiation Oncology and Image-applied Therapy
Zip code
606-8507
Address
54 Shogoin Kawaharacho Sakyo-ku, Kyoto
TEL
0757513762
kishin@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Kishi |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Radiation Oncology and Image-applied Therapy
Zip code
606-8507
Address
54 Shogoin Kawaharacho Sakyo-ku, Kyoto
TEL
075-751-3762
Homepage URL
kishin@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
Graduate School of Medicine, Kyoto University, Ethics Committe
Address
54 Shogoin Kawaharacho Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
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
| 2018 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 09 | Day |
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
| 2023 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039380
