UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005055
Receipt number R000006007
Scientific Title Adjuvant cisplatin and vinorelbine in patients with completely resected pathological II-IIIA non-small cell lung cancer.
Date of disclosure of the study information 2011/02/09
Last modified on 2017/10/16 10:50:26

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Basic information

Public title

Adjuvant cisplatin and vinorelbine in patients with completely resected pathological II-IIIA non-small cell lung cancer.

Acronym

Adjuvant CDDP + VNR for pII-III NSCLC

Scientific Title

Adjuvant cisplatin and vinorelbine in patients with completely resected pathological II-IIIA non-small cell lung cancer.

Scientific Title:Acronym

Adjuvant CDDP + VNR for pII-III NSCLC

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of adjuvant chemotherapy with cisplatin and vinorelbine for patients with completely resected pathological stage II-III non-small cell lung cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Recurrence-free survival

Key secondary outcomes

Overall survival, adverse effects


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

adjuvant chemotherapy, consisting of cisplatin and vinorelbine

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

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

Disease: patients with completely resected non-small cell lung cancer
Opetation mode: lobectomy, bilobectomy, or pneumonectomy with regional and mediastinal lymphnode disection.
Pathological stage: IIA, IIB, IIIA in UICC criteria
ECOG Performance status: 0 - 1.
No other active malignancies
Laboratory data:
WBC >= 4000 /mm3, Neutrophil >= 2000 /mm3, Hemoglobin >= 10 g/dl, Platelet >= 100,000 /mm3
GOT and GPT =< 2.5UNL
T-bil =< 1.5 mg/dl
s-Cre =< 1.5 mg/dl
PaO2 >= 65 mmHg or SpO2 >= 93%
Written informed consent

Key exclusion criteria

Patients receiving induction chemotherapy, radiotherapy for corresponding NSCLC

Patients receiving other postoperative chemotherapy / radiotherapy (Pleurodesis with OK-432 is excluded.)

Patients with other active malignancy.
Patients with active infection.
Patients with cardiac diseases which are not well-controlled.
Patients with interstitial lung diseases.
Patients with uncontrolled diabetes mellitus
Patients with a disease which needs steroid treatment
Patients who have allergy to CDDP or VNR
Patients in pregnancy or during lactation

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Date

Organization

Kyoto University Hospital

Division name

Department of Thoracic Surgery

Zip code


Address

Shogoin-Kawara-cho 54, Sakyo-ku, Kyoto

TEL

075-751-4975

Email



Public contact

Name of contact person

1st name
Middle name
Last name Makoto Sonobe

Organization

Kyoto University Hospital

Division name

Department of Thoracic Surgery

Zip code


Address

Shogoin-Kawara-cho 54, Sakyo-ku, Kyoto

TEL

075-751-4975

Homepage URL


Email

mysonobe@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Thoracic Surgery, Kyoto University Hospital

Institute

Department

Personal name



Funding Source

Organization

Donation for reseach in Department of Thoracic Surgery, Kyoto University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN


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

京都大学医学部附属病院(京都府)


Other administrative information

Date of disclosure of the study information

2011 Year 02 Month 09 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

https://link.springer.com/article/10.1007%2Fs00280-014-2595-5

Number of participants that the trial has enrolled


Results

Purpose
Adjuvant vinorelbine and cisplatin chemotherapy is recognized as a standard regimen for patients with completely resected stage II and III non-small cell lung cancer (NSCLC). However, efficacy of adjuvant chemotherapy in Japanese phase III trials with cisplatin-containing regimen has been controversial, and data are limited on the long-term outcome of adjuvant vinorelbine and cisplatin chemotherapy for NSCLC patients.

Methods
This was a single-arm phase II study in patients with completely resected pathological stage II or III NSCLC, who had not received prior chemotherapy or radiotherapy. Patients received 4 cycles of vinorelbine [25 mg/m2 of body surface area (BSA)] and cisplatin (40 mg/m2 of BSA) on days 1 and 8, every 4 weeks. Primary end point was the 3-year relapse-free survival; secondary end points were overall survival and safety.

Results
Between December 2006 and January 2011, 60 patients (40 men and 20 women, median age 64 years) were enrolled; all patients were evaluable for survival and safety. Three-year relapse-free survival rate was 55.0% (95% confidence interval 42.4-67.6%). Three- and five-year overall survival rates were 83.3 and 77.8%, respectively. There were no chemotherapy-related deaths, and adverse effects were acceptable.

Conclusions
Adjuvant vinorelbine and cisplatin chemotherapy was safe and showed a valid relapse-free survival rate. This regimen could be used as a standard regimen and deserves to be a control arm of trials on adjuvant chemotherapy in the Japanese NSCLC patient population.

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

2006 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2006 Year 12 Month 01 Day

Last follow-up date

2015 Year 12 Month 01 Day

Date of closure to data entry

2015 Year 12 Month 01 Day

Date trial data considered complete

2017 Year 06 Month 01 Day

Date analysis concluded

2017 Year 06 Month 01 Day


Other

Other related information

We are prepairing the report on the long-term results of enrolled patients.


Management information

Registered date

2011 Year 02 Month 08 Day

Last modified on

2017 Year 10 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006007


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name