UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000007986
Receipt No. R000008845
Scientific Title A Phase II study of Pemetrexed plus split Cisplatin followed by maintenance Pemetrexed in previously untreated patients with stage III/IV or recurrent post-operative non-small-cell with non-squamous lung cancer. OSAKA-LCSG1103
Date of disclosure of the study information 2012/05/18
Last modified on 2019/11/26 (Ver. 7)

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Basic information
Public title A Phase II study of Pemetrexed plus split Cisplatin followed by maintenance Pemetrexed in previously untreated patients with stage III/IV or recurrent post-operative non-small-cell with non-squamous lung cancer.
OSAKA-LCSG1103
Acronym A Phase II study of Pemetrexed plus split Cisplatin followed by maintenance Pemetrexed in previously untreated patients with stage III/IV or recurrent post-operative non-small-cell with non-squamous lung cancer.
OSAKA-LCSG1103
Scientific Title A Phase II study of Pemetrexed plus split Cisplatin followed by maintenance Pemetrexed in previously untreated patients with stage III/IV or recurrent post-operative non-small-cell with non-squamous lung cancer.
OSAKA-LCSG1103
Scientific Title:Acronym A Phase II study of Pemetrexed plus split Cisplatin followed by maintenance Pemetrexed in previously untreated patients with stage III/IV or recurrent post-operative non-small-cell with non-squamous lung cancer.
OSAKA-LCSG1103
Region
Japan

Condition
Condition over 20 years old patients in previously untreated patients stage III/IV or recurrent post-opetative non-small-cell and non-squamous lung cancer.
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of Pemetrexed plus split Cisplatin followed by maintenance Pemetrexed treatment in previously untreated patients stage III/IV or recurrent post-opetative non-small-cell and non-squamous lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes One year survival
Key secondary outcomes Progression Free Survival,
Evaluation of safety,
Response rate,
overall survival

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 Four cycles of Pemetrexed + Cisplatin followed by maintenance Pemetrexed in 21-day cycles until progression disease
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-sqamous and non-small-cell lung cancer with Chemo naive patients (Radiothrapy to any place other than primary and evaluable lesion is competent)
2)Patients who have measurable lesion (In 10mm Slice CT more than 20mm, in 5mm Slice CT more than 10mm) or evaluable lesion by RECIST
3)Stage III/IV without any indications for radiotherapy, or recurrent disease after surgery that passes more than one year from the last dosage day of adjuvant chemotherapy
5)Patients aged 20 years or older
6)ECOG 0-1
7)Adequate organ function, evaluated within 14 days before enrollment (registration day is day1, and on the same day two weeks ago, is impossible) as
WBC >= 4,000/mm3
Neu >= 2,000/mm3
Plt >= 100,000/mm3
Hb >= 9.5 g/dL over
AST/ALT, 3 of upper limit of normal or less.
T.Bil under 1.5 g/dL
Ccr >= 60mL/min, sCr:x1.2 of upper limit of normal or less.
SpO2 over 93% as room air
8)Patients are excepted to live over 3 months after administration day
9)Written informed consent from the patients


Key exclusion criteria 1)Patients have diagnosed squamous cell carcinoma
2)Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray
3) Patiens has pleural effusion, pericardial effusion and ascites to need treatment for
4) Patients unable to administer folic acid and vitamin B12, or not
5) Severe renal function disorder
6) Pregnancy, breast feeding and suspected pregnancy
7) SVC syndrome
8) Active double cancer
9) Uncontrollable diabetes mellitus and hypertenson
10) Diagnosed as liver cirrhosis by image findings or clinical laboratory
11) History of severe heart disease (uncontrollable arrythmia, uncontrollable angina pectoris, congestive heart failue, etc within 6 months)
12) Pregnancy, breast feeding and suspected pregnancy
13) Grave drug allergic reaction
14) Acute inflammatory disease
15) An agreement is not obtained for support therapy such as transfusion etc
16) Having the bleeding tendency which is clear in clinic
17) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor

Target sample size 55

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Kijima
Organization Osaka university Hosipital
Division name department of respiratory medicine
Zip code 5650871
Address 2-15,Yamadaoka,Suita-city,Osaka
TEL 06-6879-3833
Email tkijima@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Kijima
Organization Osaka university Hosipital
Division name department of respiratory medicine
Zip code 5650871
Address 2-2 Yamada-oka, Suita, Osaka 565-0871, Japan
TEL 06-6879-5111
Homepage URL
Email tkijima@imed3.med.osaka-u.ac.jp

Sponsor
Institute Department of respiratory medicine,Osala university Hospital.
Institute
Department

Funding Source
Organization Department of respiratory medicine,Osala university Hospital.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor OULCSG
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka University Clinical Research Review Committee
Address 2-2,Yamadaoka,Suita-cty, Osaka
Tel 06-6879-5111
Email rinri@hp-crc.med.osaka-u.ac.jp

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 大阪大学附属病院（大阪）

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 18 Day

Related information
URL releasing protocol https://link.springer.com/article/10.1007/s00280-018-3598-4
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007/s00280-018-3598-4
Number of participants that the trial has enrolled 53
Results 
Thirty-eight (71.7%) patients completed induction therapy, while 35 (66.0%) received maintenance therapy. The 1-year survival rate was 67.7%. The median PFS and OS were 5.3 and 18.6 months, respectively. The response rate and disease control rate (DCR) during the induction phase were 37.7 and 86.8%, respectively. Eight patients (15.1%) discontinued the therapy due to adverse events (AEs) during the induction phase, but both hematological and non-hematological AEs were infrequent.
Results date posted
2019 Year 11 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2018 Year 05 Month 04 Day
Baseline Characteristics 
See Cancer Chemother Pharmacol, 2018;82(1);111-7.
Participant flow 
See Cancer Chemother Pharmacol, 2018;82(1);111-7.
Adverse events 
See Cancer Chemother Pharmacol, 2018;82(1);111-7.
Outcome measures 
See Cancer Chemother Pharmacol, 2018;82(1);111-7.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 01 Month 29 Day
Date of IRB
2012 Year 01 Month 31 Day
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
2016 Year 03 Month 05 Day
Date of closure to data entry
2017 Year 05 Month 27 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 05 Month 18 Day
Last modified on
2019 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008845