UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021226 |
|---|---|
| Receipt number | R000024462 |
| Scientific Title | A phase I trial of weekly Nedaplatin and concurrent thoracic radiotherapy for elderly patients with locally advanced squamous cell lung cancer |
| Date of disclosure of the study information | 2016/02/29 |
| Last modified on | 2020/03/04 08:04:06 |
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Basic information
Public title
A phase I trial of weekly Nedaplatin and concurrent thoracic radiotherapy for elderly patients with locally advanced
squamous cell lung cancer
Acronym
Nedaplatin and thoracic radiation Phase 1
Scientific Title
A phase I trial of weekly Nedaplatin and concurrent thoracic radiotherapy for elderly patients with locally advanced
squamous cell lung cancer
Scientific Title:Acronym
Nedaplatin and thoracic radiation Phase 1
Region
| Japan |
Condition
Condition
elderly patients with locally advanced
squamous cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the recommended dose and assess the safety of chemoradiotherapy with nedaplatin and thoracic radiation in elderly patients with locally advanced squamous celllung cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
To determine the recommended dose and assess the safety of chemoradiotherapy with nedaplatin and thoracic radiation
Key secondary outcomes
response rate, progression free survival, overall survival, 2 year survival rate, , completion rate of chemoradiotherapy, the rate of occurrence of grade 3 and more radiation pneumonitis
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
Combination of Nedaplatin and concurrent thoracic radiotherapy 2Gy/day for 30 times. The dose escalation of Nedaplatin is conducted from 20 to 30 mg/m2 according to standard 3+3 design.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Cytologically or histologically comfirmed squamous cell carcinoma of the lung
2 Previously untreated and unresectable Stage 3A or 3B
3 patients aged 75 and more years old
who are amenable for standard chemo-
radiotherapy
4 Eastern Cooperative Oncology Group Performance Status 0 to 1
5 An approval of a radiotherapist by CT simulation based on the restriction of this protcol before registration.
6 Have adequate organ function within two week before study entry
a)leukocyte 3000/mm3 or higher
b)absolute neutrophil count 1500/mm3 or higher
c) hemoglobin consentration 9.0g/dl or higher
d) serum AST and ALT 2.5 times of the institutional upper limits of normal or lower
e) serum bilirubin 1.5mg/dl or lower
f) serum creatinine 1.2mg/dl or lower
g) creatinine clearance 60ml/min or higher
7 Have signed an informed consent document
Key exclusion criteria
1) SVC syndrome
2) Pulmonary fibrosis and interstitial pneumonitis
3) With active double cancer
4) With active infection, poorly controlled diabetes, and serious cardiac diseases
5) Patients with steroid treatment
6) Clinically significant drug allergy
7) Uncontrolled psychiatric disease.
8) Positive serum HBs antigen or HCV antibody
9) Others
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhito Fujisaka |
Organization
Osaka medical college hospital
Division name
Cancer research center
Zip code
Address
2-7, Daigakumachi, Takatsuki city, Osaka, Japan
TEL
072-683-1221
fujisaka_y@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Tamura |
Organization
Osaka medical college hospital
Division name
First Department of Internal Medicine
Zip code
Address
2-7, Daigakumachi, Takatsuki city, Osaka, Japan
TEL
072-683-1221
Homepage URL
in1285@osaka-med.ac.jp
Sponsor or person
Institute
Osaka medical college hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 02 | Month | 29 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | 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
| 2016 | Year | 02 | Month | 27 | Day |
Last modified on
| 2020 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024462
