UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004833 |
|---|---|
| Receipt number | R000005754 |
| Scientific Title | Phase 2 study of the combination of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer |
| Date of disclosure of the study information | 2011/01/06 |
| Last modified on | 2022/01/14 12:55:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase 2 study of the combination of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer
Acronym
Phase 2 study of the combination of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer
Scientific Title
Phase 2 study of the combination of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer
Scientific Title:Acronym
Phase 2 study of the combination of gemcitabine and nedaplation for treatment of previously untreated advanced squamous cell lung cancer
Region
| Japan |
Condition
Condition
Lung squamous cell carcinoma
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of gemcitabine and nedaplatin in patients with previously untreated squamous cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression-free survival
Overall Survival
Toxicity
Feasibility(Dose Intensity)
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 chemotherapy with gemcitabine and nedaplation
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 cytologically proven squamous cell lung cancer.
2) Stage III/IV without indication for curative resection and post-operative recurrent disease.
3) Target lesion is measurable(RECISTver1.1).
4) Patients aged 20 or over.
5) ECOG performance status 0-1.
6) Sufficient function of main organ and bone marrow filled the following criteria before two weeks from enrollment:
Leukocyte counts, 4,000/mm3 to 12,000/mm3.
Neutrophil counts, 2,000/mm3 or over.
Platelets, 100,000/mm3 or over.
Hemoglobin, 9.0g/dL or over
AST and ALT, x 2.5 of upper limit of normal (ULN) or less.
Serum bilirubin, 1.5mg/dl or less.
Serum creatinin, x 1.5 of ULN or less.
Arterial oxygen partial pressure 60 Torr or above.
Adequate heart function by ECG.
LVEF, 60% or over.
7) Patients without active interstitial pneumonia recognized by chest X-ray.
8) Excepted to live over 12 weeks after administration day.
9) Written informed consent from the patients.
Key exclusion criteria
1) Active infectious disease
2) Patients with fever above 38 degrees.
3) Patients with severe complications.
4) Active concominant malignancies.
5) Patients with symptomatic brain metastasis.
6) Pleural effusion, pericardial effusion and ascites to need treatment
7) Patients with a history of hypersensitivity to the gemcitabine or nedaplation.
8) History of pregnancy or lactation.
9) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | FUNAI Kazuhito |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka. Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka. Japan
TEL
Homepage URL
Sponsor or person
Institute
First Department of Surgery, Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
磐田市立総合病院（静岡県）、聖隷浜松病院（静岡県）、浜松医療センター（静岡県）、藤枝市立総合病院（静岡県）、富士宮市立病院（静岡県）、焼津市立総合病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 06 | 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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2010 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2011 | Year | 01 | Month | 06 | Day |
Last modified on
| 2022 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005754
