UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006976 |
|---|---|
| Receipt number | R000008229 |
| Scientific Title | Randomized phase II trial evaluating epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TKI) plus chemotherapy in non-small cell lung cancer (NSCLC) patients with previously treated EGFR-TKI. |
| Date of disclosure of the study information | 2011/12/28 |
| Last modified on | 2016/10/06 14:58:04 |
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Basic information
Public title
Randomized phase II trial evaluating epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TKI) plus chemotherapy in non-small cell lung cancer (NSCLC) patients with previously treated EGFR-TKI.
Acronym
LOGIK 1102: Standard chemotherapy versus EGFR-TKI plus chemotherapy beyond progression (CVEC) study.
Scientific Title
Randomized phase II trial evaluating epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TKI) plus chemotherapy in non-small cell lung cancer (NSCLC) patients with previously treated EGFR-TKI.
Scientific Title:Acronym
LOGIK 1102: Standard chemotherapy versus EGFR-TKI plus chemotherapy beyond progression (CVEC) study.
Region
| Japan |
Condition
Condition
NSCLC with previously treated EGFR-TKI.
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluating efficacy of EGFR-TIK plus chemotherapy in NSCLC patients with previously treated EGFR-TKI.
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
Key secondary outcomes
Disease control rate at 6,8,12weeks
Overall survival
Adverse Event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A:Reference arm
Single-agent chemotherapy
Interventions/Control_2
B:Experimental arm
Single-agent chemotherapy plus EGFR-TKI
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. Pathologically or cytplogically confirmed non-small cell lung cancer.
2. Patients with clinical stage IIIB, IV or postoperative recurrence, and unsuitable for radiotherapy. Patients have previously treated with platinum-based chemotherapy as a 1st-line.
*Adjuvant and neo-adjuvant chemotherapy are not considered as one regimen of chemotherapy before 12 months.
*Pleurodesis with OK432 or bleomycin are not considered as one regimen of chemotherapy.
3. Patients have previously treated with EGFR-TKI as a 2nd-line or more chemotherapy, and have a disease control at least 8weeks.
4. Within 42 days after disease progression.
5. Patients have treated radiotherapy who have uncontrollable brain metastases.
6. Patients with evaluable disease (not necessarily to be measurable)
7. Age eligible for study: 20 years and above
8. ECOG PS 0-2
9. Sufficient organ function
WBC >=2000/mm3, Hb >=9.0 g/dL
Plt >=100000/mm3
Bil =<1.5mg/dL
GOT/GPT <=100IU/L
Cr. =<1.2mg/dL
SpO2>=92%
10. Patients are expected to live over 12 weeks.
11. Written informed consent
Key exclusion criteria
1. Patients could not received EGFR-TKI (gefitinib 250mg or erlotinib 150mg) more than evry 3 days.
2. History of symptomatic brain metastases.
3. History of obvious and widely distributed interstitial pneumonia or pulmonary fibrosis detected by chest X-ray.
4. History of radiation therapy for mediastinum or lung within 28 days at the time of entry. (Radiation therapy for other parts is not adapted for this exclusion cliteria.)
5. History of poorly controlled pleural effusion, pericardial. effusion or ascites necessitating drainage.
6. History of major surgery within 28 days.
7. History of active infection.
8. History of active double cancer
9. History of severe drug allergy
10. History of pregnancy or lactation
11. Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Sugio |
Organization
Oita University
Division name
Department of Thoracic and Breast surgery
Zip code
Address
1-1 Idaigaoka,Hasama-machi,Yufu-city,Oita,879-5593,Japan
TEL
092-541-3231
ksugio@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumihiko Hirai, Takashi Seto |
Organization
National Kyushu Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
3-1-1 Notame, Minami-ku, Fukuoka 811-1395, Japan
TEL
092-541-3231
Homepage URL
hirai.f@nk-cc.go.jp
Sponsor or person
Institute
Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Support Center Kyushu
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
| 2011 | Year | 12 | Month | 28 | 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
| 2011 | Year | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | 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
| 2011 | Year | 12 | Month | 28 | Day |
Last modified on
| 2016 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008229
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