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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000006737
Receipt No. R000007955
Scientific Title Randomized Phase III Study of Pemetrexed + Cisplatin and Vinorelbine + Cisplatin for Completely Resected Non-squamous Non-Small Cell Lung Cancer
Date of disclosure of the study information 2011/11/17
Last modified on 2020/05/23

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Basic information
Public title Randomized Phase III Study of Pemetrexed + Cisplatin and Vinorelbine + Cisplatin for Completely Resected Non-squamous Non-Small Cell Lung Cancer
Acronym Phase III Study of PEM + CDDP and VNR + CDDP for Completely Resected Non-squamous Non-Small Cell Lung Cancer
Scientific Title Randomized Phase III Study of Pemetrexed + Cisplatin and Vinorelbine + Cisplatin for Completely Resected Non-squamous Non-Small Cell Lung Cancer
Scientific Title:Acronym Phase III Study of PEM + CDDP and VNR + CDDP for Completely Resected Non-squamous Non-Small Cell Lung Cancer
Region
Japan

Condition
Condition Completely resected non-squamous non-small cell lung cancer patients (pathologic stage II-IIIA)
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of pemetrexed + cisplatin in completely resected non-squamous non-small cell lung cancer by randomized comparison with the standard therapy of vinorelbine + cisplatin and to establish the standard post-operative adjuvant chemotherapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Key secondary outcomes Disease-free survival
Rate of treatment completion
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 considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pemetrexed + Cisplatin
Interventions/Control_2 Vinorelbine + Cisplatin
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 confirmed non-squamous NSCLC. Adenosquamous carcinoma is eligible if the squamous cell carcinoma component is less than 50%.
2) Pathologic stage II or IIIA (UICC TNM Classification 7th edition)
3) Proven EGFR gene mutation status (Exon19 deletion/ Exon21 L858R; present/ absent) (regardless of the type of determination method)
4) Complete resection* is pathologically confirmed.
*Complete resection is the surgical procedure which removes lung cancer to the R0 level. However, when cancer metastasis is found in the uppermost part of a dissected or sampled lymph node in R0 (un) cases, the case is defined as "incomplete resection". R1 (is) and R1(cy+) are also defined as "incomplete resection".
5) The level of surgical resection is higher than lobectomy.
6) ND2a-1 or higher-level lymph node dissection or selective lymph node dissection has been conducted.
7) No other treatments except surgery have been carried out for lung cancer.
8) The age is within 20-75 years inclusive.
9) A performance status (ECOG) of 0 or 1.
10) Registration was made at 21 or more days after surgery but within 56 days after surgery.
11) The functions of the main organs are maintained, and all the criteria stated below are satisfied.
(Laboratory test values should be the most recent findings obtained within 14 days before registration, although the findings made 2 weeks previously are acceptable, if they were obtained on the same day of the week as that of the date of registration.)
* Hemoglobin: >=9.0 g/dl
* WBC: >=3000/mm3 (Neutrophil count: >=1500/mm3)
* Platelet count: >=100,000/mm3
* Both AST and ALT: <=100 IU/L
* Total bilirubin: <=1.5 mg/dl
* Serum creatinine: <=1.5 mg/dl
* Creatinine clearance: >=60 ml/min (actual measurement or the value obtained using the Cockcroft-Gault formula)
12) PaO2: >=70 Torr or SpO2: >=95% in the state of no oxygen inhalation (room climate)
13) Submission of written informed consent concerning study participation.
Key exclusion criteria 1) Have active double cancer (synchronous double cancer and metachronous double cancer within a 5-year disease-free interval are defined as active double cancer; in situ uterocervical carcinoma judged to be curable by topical therapy, gastric/colorectal cancer resectable by endoscopy, and topically resectable active skin diseases, except malignant melanoma, are not included in active double cancer); however, a patient is eligible even if double primary NSCLC is observed in the resected lung.
2) Previously treated with cisplatin, pemetrexed or vinorelbine
3) Administration of folic acid or Vitamin B12 is not possible.
4) Serious post-operative complications (post-operative infections, suture failures, etc.)
5) Interstitial shadow considered to be clearly indicative of interstitial pneumonia on chest CT
6) Active infection
7) Requirement of continuous systemic administration (oral or intravenous) of steroid at a dose > 10 mg/day in the case of prednisolone, and the current use of an immunosuppressant; however, patients currently treated with oral steroid at a dose of 10 mg/day in case of prednisolone can be enrolled in the study.
8) Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period and lactating women.
Men who will not be compliant with a contraceptive regimen during and for 6 months after the treatment period.
9) History of serious drug hypersensitivity
10) Other serious complications
11) Others judged by the investigator to be unsuitable for the study
Target sample size 800

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Tsuboi
Organization National Cancer Center Hospital East
Division name Devision of Thoracic Surgery
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
TEL 04-7133-1111
Email mtsuboi@za2.so-net.ne.jp

Public contact
Name of contact person
1st name Hirotsugu
Middle name
Last name Kenmotsu
Organization Shizuoka Cancer Center
Division name Division of Thoracic Oncology
Zip code 4110942
Address 1007 Shimonagakubo Nagaizumi-cho Sunto-gun,Shizuoka, Japan, 411-8777
TEL 055-989-5222
Homepage URL http://www.fuji-pvc.jp/center/jipang/index.aspx
Email h.kenmotsu@scchr.jp

Sponsor
Institute Steering committee for Randomized Phase III Study of Cisplatin + Pemetrexed and Cisplatin + Vinorelbine for Completely Resected Non-squamous Non-Small Cell Lung Cancer
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor TCOG, TORG, CJLSG, West Japan Oncology Group, JMTO, Setouchi Lung Cancer Study Group, LOGIK.
Name of secondary funder(s) Tokyo Cooperative Oncology Group, Thoracic Oncology Research Group, Central Japan Lung Study Group, Japan-Multinational Trial Organization, Lung Oncology Group in Kyushu.

IRB Contact (For public release)
Organization Shzioka Cancer Center Certified Clinical Research Review Committee
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun
Tel 0559895222
Email rinsho_office@scchr.jp

Secondary IDs
Secondary IDs YES
Study ID_1 jRCTs041180023
Org. issuing International ID_1 Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 804
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 Main results already published
Date of protocol fixation
2011 Year 02 Month 08 Day
Date of IRB
2011 Year 04 Month 01 Day
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2021 Year 08 Month 19 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 11 Month 16 Day
Last modified on
2020 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007955

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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