UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004876 |
|---|---|
| Receipt number | R000005804 |
| Scientific Title | Randomized phase II study of pemetrexed plus cisplatin or carboplatin followed by pemetrexed in chemotherapy-naive patients with non-squamous non-small cell lung cancer |
| Date of disclosure of the study information | 2011/01/15 |
| Last modified on | 2023/07/25 11:47:39 |
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Basic information
Public title
Randomized phase II study of pemetrexed plus cisplatin or carboplatin followed by pemetrexed in chemotherapy-naive patients with non-squamous non-small cell lung cancer
Acronym
Randomized phase II study of pemetrexed plus cisplatin or carboplatin followed by pemetrexed in chemotherapy-naive patients with non-squamous non-small cell lung cancer
Scientific Title
Randomized phase II study of pemetrexed plus cisplatin or carboplatin followed by pemetrexed in chemotherapy-naive patients with non-squamous non-small cell lung cancer
Scientific Title:Acronym
Randomized phase II study of pemetrexed plus cisplatin or carboplatin followed by pemetrexed in chemotherapy-naive patients with non-squamous non-small cell lung cancer
Region
| Japan |
Condition
Condition
non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It verifies that PFS is 4.5 months or more in each arm.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
PFS: progression free survival
It verifies that PFS is 4.5 months or more in each arm.
Key secondary outcomes
QOL: quality of life
RR: response rate
DCR: disease control rate
OS: overall survival
Maintenance treatment shift rate
AE: adverse events
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
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pemetrexed after induction therapy of pemetrexed plus cisplatin
Interventions/Control_2
Pemetrexed after induction therapy of pemetrexed plus carboplatin
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically confirmed non-squamous non-small cell lung cancer. (Non-Squamous NSCLC).
2)Stage III/IV unresectable or unsuitable for radical irradiation or postoperative recurrent Non-Squamous NSCLC.
3)No prior chemotherapy or post-operative recurrent disease without adjuvant chemotherapy or with at least six months interval from the last dosage of adjuvant chemotherapy.
4) Measurable tumor sites
5) ECOG-PS of 0 or 1.
6)No prior systemic anticancer therapy including palliative brain or bone irradiation within 2 weeks of proposed entry to this trial.
7) Life expectancy more than 3 months.
8) Adequate organ function.
9) Written informed consent from the patients.
Key exclusion criteria
1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan.
2)Patients with active co-morbidities including severe conditions.
(1)uncontrollable angina pectoris, myocardial infarction within 3 months, severe heart disease.
(2)uncontrollable diabetes, hypertension.
(3)severe infection
(4)paresis of intestine, illeus
(5)Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
3)Patients with massive pleural and cardiac effusion and ascites that need to be immediately treated.
4) Brain metastases with neurological symptoms.
5) SVC syndrome.
6) Active double cancer.
7)Pregnancy, breast feeding and suspected pregnancy.
8)History of grave drug allergic reaction.
9) Psychiatric disorder.
10) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiko Ikeda |
Organization
Tokyo Medical University
Division name
Department of Surgery
Zip code
Address
6-7-1 Nishi-shinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
TEL
03-3342-6111
ikeda-n@tokyo-med.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 108-8329, Japan.
TEL
03-3454-0067
Homepage URL
snagase@iuhw.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
慶応義塾大学病院 呼吸器内科（東京都）
至誠会第二病院 呼吸器内科（東京都）
聖路加国際病院 呼吸器内科（東京都）
東京医科歯科大学医学部附属病院 呼吸器内科（東京都）
東京女子医科大学病院 呼吸器内科（東京都）
日本医科大学付属病院 呼吸器内科（東京都）
複十字病院 呼吸器内科（東京都）
東京医療センター 呼吸器科（東京都）
日本赤十字社医療センター 化学療法科/呼吸器内科（東京都）
東京医科大学病院 呼吸器・甲状腺外科（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 15 | 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
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 14 | Day |
Last modified on
| 2023 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005804
