UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004634
Receipt number R000005528
Scientific Title The Phase II Study of Docetaxel plus Nedaplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer
Date of disclosure of the study information 2010/11/30
Last modified on 2010/11/30 16:23:47

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Basic information

Public title

The Phase II Study of Docetaxel plus Nedaplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer

Acronym

The Phase II Study of Docetaxel plus Nedaplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer

Scientific Title

The Phase II Study of Docetaxel plus Nedaplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer

Scientific Title:Acronym

The Phase II Study of Docetaxel plus Nedaplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer

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 feasibility of docetaxel plus nedaplatin as adjuvant chemotherapy in patients with completely resected non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Feasibility

Key secondary outcomes

Disease-free survival
Overall survival
Safety


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Docetaxel (60mg/m2) (day 1) +
Nedaplatin (80mg/m2) (day 1)
q4weeks, 4 cycles

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

79 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Histologically determined non-small cell lung cancer
2. Completely resected
3. Pathological stage IB, IIA, IIB, IIIA
4. Neither previous chemotherapy nor radiotherapy as adjuvant therapy
5. Aged 20-79 years old
6. ECOG performance status 0 or 1
7. Adequate organ function
8. Possible to receive chemotherapy within 4-8 months after surgery
9. Written informed consent

Key exclusion criteria

1. Allergy against polysorbert 80 or platinum-containing drugs
2. Severe complications
(i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infarction within 6 months, liver cirrhosis, uncontrolled diabetes, hemorrhagic tendency)
3. Active infections
4. Massive pleural or pericardial effusion
5. Active simultaneous cancer
6. Active interstitial pneumonitis or its past history
6. Peripheral nerve disorders
7. Pregnant or lactating women
8. Other conditions not suitable for this study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriaki Tezuka

Organization

Shiga University of Medical Science

Division name

Department of Surgery

Zip code


Address

Seta-Tsukinowa, Otsu, Shiga

TEL

077-548-2244

Email



Public contact

Name of contact person

1st name
Middle name
Last name Koji Teramoto

Organization

Shiga University of Medical Science

Division name

Department of Surgery

Zip code


Address

Seta-Tsukinowa, Otsu, Shiga

TEL

077-548-2244

Homepage URL


Email



Sponsor or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



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

滋賀医科大学医学部附属病院(滋賀県)
国立病院機構京都医療センター(京都府)


Other administrative information

Date of disclosure of the study information

2010 Year 11 Month 30 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


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

Enrolling by invitation

Date of protocol fixation

2010 Year 10 Month 12 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 11 Month 30 Day

Last modified on

2010 Year 11 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005528


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name