UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000007955