UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

Overall survival

Key secondary outcomes

Disease-free survival
Rate of treatment completion
Adverse events

Study type

Interventional

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

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

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

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

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

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

Personal name

Organization

AMED

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

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.

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

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

Date of disclosure of the study information

2011

Year

11

Month

17

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2011

Year

11

Month

16

Day

Last modified on

2020

Year

05

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007955