UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016550 |
|---|---|
| Receipt number | R000019209 |
| Scientific Title | Untreated IIIB/IV period with the EGFR mutation in the gene, phase II study of Gefitinib and the pemetrexed / bevacizumab combination maintenance therapy after Gefitinib and the cisplatin / pemetrexed / bevacizumab combination induction therapy for non-squamous epithelium non-small cell lung cancer of the latter recurrence |
| Date of disclosure of the study information | 2015/02/16 |
| Last modified on | 2016/08/17 16:13:22 |
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Basic information
Public title
Untreated IIIB/IV period with the EGFR mutation in the gene, phase II study of Gefitinib and the pemetrexed / bevacizumab combination maintenance therapy after Gefitinib and the cisplatin / pemetrexed / bevacizumab combination induction therapy for non-squamous epithelium non-small cell lung cancer of the latter recurrence
Acronym
Untreated IIIB/IV period with the EGFR mutation in the gene, phase II study
Scientific Title
Untreated IIIB/IV period with the EGFR mutation in the gene, phase II study of Gefitinib and the pemetrexed / bevacizumab combination maintenance therapy after Gefitinib and the cisplatin / pemetrexed / bevacizumab combination induction therapy for non-squamous epithelium non-small cell lung cancer of the latter recurrence
Scientific Title:Acronym
Untreated IIIB/IV period with the EGFR mutation in the gene, phase II study
Region
| Japan |
Condition
Condition
non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We examine Gefitinib and Gefitinib after the cisplatin / pemetrexed / bevacizumab combination induction therapy and efficacy and safety of the pemetrexed / bevacizumab combination maintenance therapy for non-squamous epithelium non-small cell lung cancer of the postoperative recurrence untreated IIIB/IV period with the EGFR mutation in the gene.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
1-year progression free survival rate
Key secondary outcomes
RR response rate
DCP disease Control proportion
OS overall survival
PFS progression free survival
AEs Adverse Events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Randomization phase II study of the maintenance therapy with chemotherapy non-enforcement IIIB/IV period, pemetrexed following induction therapy with pemetrexed / cisplatin for patients with postoperative recurrent non-squamous epithelium non-small cell lung cancer or carboplatin
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-squamuous, non-small cell lung cancer and stage IV or recurrent non-small cell lung cancer
2 A stage IIIB the clinic that radical irradiation is impossible of or stage IV and postoperative recurrence symptom example.
3 With the EGFR active form mutation in the gene more than G719X, 19del, L858R, one one of L861Q.
4 The case that recurred after the above after last administration for half a year of chemotherapy non-enforcement or the postoperative adjuvant chemotherapy.
We exclude the case given Gefitinib or pemetrexed as postoperative adjuvant chemotherapy.
Also, we do not include the picibanil which we used in pleurodesis and the minocycline in chemotherapy.
5 The age of the agreement acquisition day is a case younger than 75 years 20 years old or older.
6 ECOG Performance Status 0-1
7 With one or more measurable lesions based on RECIST version 1.1
8 Adequate organ function
9 The case that the survival that is more three months or more than the treatment starting date can expect.
10 An orally-available case.
11 The case that an agreement by the free will of the patients is obtained in a document about participation of this study.
Key exclusion criteria
1) The case that a squamous cancer ingredient accounts for more than 50% in the case of mixed type with the squamous cancer.
2) A mixed case with small cell lung cancer.
3) We have EGFR resistance gene mutation (T790M).
4) With the symptom or metastases to brain case to need treatment such as a steroid or the antispasmodic.
5) The case with a history of the hemoptysis or the merger.
6) The case with a history, the merger of the following sputum bloody.d
7) A case that was given the radiotherapy for the chest.
8) It is a case of after the palliative irradiation for bone metastases or the metastases to brain except the primary tumor for less than two weeks.
9) The invasion of the primary tumor is found in in great vessels in trachea or lobar bronchus or the TNM classification T4 of the lung cancer handling agreement revision seventh edition partly.
10) A case with the superior vena caval syndrome.
11) A case with the interstitial pneumonia that is clear by chest CT or pulmonary fibrosis.
12) The case with a serious infection.
13) The case with serious complications.
14) The case with pleural effusion, ascitic fluid requiring treatment such as the drainage and the pericardial fluid.
15)A case with the multiple primary cancer of the activity.
16)A case with a history of serious drug allergy.
17)Uncontrollable hypertension < 160/100
18) A case with a history of less than one year before merger of cerebrovascular disorder with the symptom or registration.
19) Need to antiplatelet therapy or anticoagulation therapy without Aspirin 325 mg/day
20) Gastrointestinal perforation within 1 year
21) The case that it was judged mental disorder to become the clinical problem to have difficulty in registration to this study.
22) With pregnancy and the pregnant likelihood or women nursing or men in hope of fertility.
23)Inappropriate for this study judged by the attending physician
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seisuke Nagase |
Organization
International University of Health and Welfare
Division name
Respiratory Disease Center
Zip code
Address
1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL
03-3451-8121
snagase@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seisuke Nagase |
Organization
International University of Health and Welfare
Division name
Respiratory Disease Center
Zip code
Address
1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL
03-3451-8121
Homepage URL
snagase@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Respiratory Disease Center
Institute
Department
Personal name
Funding Source
Organization
non
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
東京医科大学病院 呼吸器・甲状腺外科（東京都）
国際医療福祉大学三田病院 呼吸器センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 16 | 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
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 16 | Day |
Last modified on
| 2016 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019209
