UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000005221
Receipt No. R000006203
Scientific Title A phase II study of pemetrexed plus carboplatin followed by pemetrexed maintenance therapy in chemotherapy-naive elderly patients with non-squamous non-small cell lung cancer
Date of disclosure of the study information 2011/03/09
Last modified on 2019/10/10 (Ver. 19)

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Basic information
Public title A phase II study of pemetrexed plus carboplatin followed by pemetrexed maintenance therapy in chemotherapy-naive elderly patients with non-squamous non-small cell lung cancer
Acronym A phase II study of pemetrexed plus carboplatin followed by pemetrexed maintenance therapy in chemotherapy-naive elderly patients with non-squamous non-small cell lung cancer
Scientific Title A phase II study of pemetrexed plus carboplatin followed by pemetrexed maintenance therapy in chemotherapy-naive elderly patients with non-squamous non-small cell lung cancer
Scientific Title:Acronym A phase II study of pemetrexed plus carboplatin followed by pemetrexed maintenance therapy in chemotherapy-naive elderly patients with non-squamous non-small cell lung cancer
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 Objective of the study is to investigate efficacy and safety of carboplatin plus pemetexed for elderly patients with untreated non-small, non-squamous cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 1 year survival
Key secondary outcomes Response rate
Disease control rate
Progression free Survival
Overall survival
Adverse events
QOL(EQ-5D,VAS scale)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
70 years-old <=
Age-upper limit
85 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.>=70years-old,<85years-old
7.It is acceptable incorporated if it is determined that bone metastases is stable.
8.Life expectancy more than 3 months.
9.Adequate organ function.
WBC count:>=4,000/mm3
neutrophil count:>=2,000/mm3
Platelet count:>=100,000/mm3
Hemoglobin:>=9.0g/dl
AST,ALT<=100IU/l
Total bilirubin:<=2.0mg/dl
creatinine:<=1.2mg/dl
PaO2 or SpO2:>=60torr or >=90%
10.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.
*uncontrollable angina pectoris, myocardial infarction within 3 months, severe heart disease.
*uncontrollable diabetes, hypertension.
*severe infection
*paresis of intestine, illeus
*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 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kaneko
Organization Yokohama City University Medical Center
Division name Respiratory Disease Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email takeshi@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaharu Shinkai
Organization Yokohama City University Hospital
Division name Respiratory medicine
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-787-2800
Homepage URL
Email shinkai@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
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
Email

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 横浜市立大学附属市民総合医療センター（神奈川県）
大和市立病院（神奈川県）
神奈川県立がんセンター（神奈川県）
藤沢市民病院（神奈川県）
関東労災病院（神奈川県）
横浜南共済病院（神奈川県）
横浜市立大学附属病院（神奈川県）
防衛医科大学校病院（埼玉県）
国立病院機構横浜医療センター（神奈川県）
横浜栄共済病院（神奈川県)
医凰会並木病院（埼玉県）
済生会横浜市南部病院（神奈川県）

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 09 Day

Related information
URL releasing protocol None
Publication of results Unpublished

Result
URL related to results and publications Asia-Pacific Journal of Clinical Oncology(submitted)
Number of participants that the trial has enrolled 43
Results 
The 1-year survival rate was 73%(95% confidence interval(CI)56_84%).RR was 43.9%,DCR was 80.5%,median PFS was 7.23 months(95%CI 3.98_9.20), and median OS was 17.41 months(95%CI 13.60_22.83).Twenty-one patients(51.2%)were transitioned to aintenance therapy.Carboplatin and pemetrexed followed by maintenance pemetrexed for non-squamous non-small cell lung cancer in elderly patients was effective and tolerable.
Results date posted
2019 Year 10 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Mean age was 75.1 years.The1-year survival rate was 73%(95% confidence interval(CI)56_84%).RR was 43.9%,DCR was 80.5%,median PFS was 7.23 months(95%CI 3.98_9.20),and median OS was 17.41 months(95%CI 13.60_22.83).
Participant flow 
Forty-three patients were enrolled between March 2011 and April 2016.
Adverse events 
Toxicities of Grade 3 or higher during the induction phase included anemia (37%), thrombocytopenia (29%), neutropenia (22%), appetite loss (15%), nausea (10%), bacterial pneumonia (7%), febrile neutropenia (5%), and interstitial pneumonia (2%). Treatment was discontinued in the two patients with interstitial pneumonia, but no deaths were encountered.
Outcome measures 
The 1-year survival rate was 73%(95% confidence interval(CI)56_84%).RR was 43.9%,DCR was 80.5%,median PFS was 7.23 months(95%CI 3.98_9.20), and median OS was 17.41 months(95%CI 13.60_22.83).Twenty-one patients(51.2%)were transitioned to aintenance therapy.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 11 Month 04 Day
Date of IRB
2010 Year 11 Month 25 Day
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
2017 Year 01 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective Study

Management information
Registered date
2011 Year 03 Month 09 Day
Last modified on
2019 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006203