UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017791 |
|---|---|
| Receipt number | R000020611 |
| Scientific Title | Phase II trial of gemcitabine monotherapy in the third or further line for pretreated patients with advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2015/06/04 |
| Last modified on | 2016/08/05 13:24:13 |
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Basic information
Public title
Phase II trial of gemcitabine monotherapy in the third or further line for pretreated patients with advanced non-small cell lung cancer
Acronym
OPH-RM-LC-1502
Scientific Title
Phase II trial of gemcitabine monotherapy in the third or further line for pretreated patients with advanced non-small cell lung cancer
Scientific Title:Acronym
OPH-RM-LC-1502
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate an effect and safety of gemicitabine monotherapy for pre-treated patients with advanced non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival(PFS)
Key secondary outcomes
Response rate (RR), Overall survival (OS), 1yr-survival rate, adverse effects, QOL assessment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
gemcitabine monotherapy (1000mg/m2, Day1,8,15, every four week)
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 confirmed non-small cell lung cancer
2) Stage III / IV or recurrence after surgery, without any indications for radiotherapy or surgery
3) Evaluable disease
4) Progressive disease or recurrence after one or more platinum-based regimens, two or more regimens containing cytotoxic drugs, docetaxel- or pemetrexed-containing regimen for non-squamaous cell carcinoma histology, and docetaxel-containing regimen for squamous cell carcinoma histology. Adjuvant platinum-based chemotherapy was considered as one regimen.
5) Pre-treated with EGFR-TKI in patients with active EGFR mutation.
6) Pre-treated with ALK inhibitor in ALK-positive patient
7) Interval; two week after thoracic radiotherapy
8) Age 20 year-old or over 20 year-old
9) ECOG Performance status 0-2
10) Adequate organ function, evaluated within 14 days before enrollment
11) Expected 12 weeks survival
12) Written informed consent
Key exclusion criteria
1) A history of gemcitabine treatment
2) Current or previous history of pulmonary fibrosis, interstitial pneumonitis or drug-induced pneumonia, revealed by chest X-ray film
3) Concurrent thoracic radiotherapy
4) A history of severe hypersensitivity against gemcitabine
5) Another active advanced malignancy that requires any concurrent treatment with treatment for lung cancer
6) Pleural effusion, ascites or peri-cardiac effusion requiring dranage.
7) Problematic complications
8) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
9) Decision of ineligibility by a physician
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seigo Minami |
Organization
Osaka Police Hospital
Division name
Dept. of Respiratory Medicine
Zip code
Address
10-31 Kitayama-cho, Tennoji-ku, Osaka-city, Osaka 543-0035, Japan
TEL
06-6771-6051
seigominami@oph.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seigo Minami |
Organization
Osaka Police Hospital
Division name
Dept. of Respiratory Medicine
Zip code
Address
10-31 Kitayama-cho, Tennoji-ku, Osaka-city, Osaka 543-0035, Japan
TEL
06-6771-6051
Homepage URL
seigominami@oph.gr.jp
Sponsor or person
Institute
Dept.Repiratory Medicine, Osaka Police Hospital
Institute
Department
Personal name
Funding Source
Organization
Dept.Repiratory Medicine, Osaka Police Hospital
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
大阪警察病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 04 | 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
| 2015 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 04 | 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
| 2015 | Year | 06 | Month | 03 | Day |
Last modified on
| 2016 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020611
