UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007986 |
|---|---|
| Receipt number | 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 15:26:59 |
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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
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
tkijima@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of respiratory medicine,Osala university Hospital.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008845
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