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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005055
Receipt No. 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

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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
Institute Department of Thoracic Surgery, Kyoto University Hospital
Institute
Department

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
URL(English) https://upload.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


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