UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000599
Receipt number R000000697
Scientific Title A phase II study of preoperative concurrent chemoradiotherapy with cisplatin and docetaxel in patients with locally advanced non-small-cell lung cancer
Date of disclosure of the study information 2007/02/08
Last modified on 2019/08/22 16:45:31

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Basic information

Public title

A phase II study of preoperative concurrent chemoradiotherapy with cisplatin and docetaxel in patients with locally advanced non-small-cell lung cancer

Acronym

A phase II study of preoperative concurrent chemoradiotherapy for
non-small-cell lung cancer

Scientific Title

A phase II study of preoperative concurrent chemoradiotherapy with cisplatin and docetaxel in patients with locally advanced non-small-cell lung cancer

Scientific Title:Acronym

A phase II study of preoperative concurrent chemoradiotherapy for
non-small-cell lung cancer

Region

Japan


Condition

Condition

resectable locally advanced non small cell lung cancer

Classification by specialty

Pneumology Surgery in general Chest surgery
Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The present study is planned to assess the feasibility and effectiveness of the chemoradiotherapy as preoperative treatment in patients with stage IIIA or IIIB disease of which mediastinal lymph node metastasis is confirmed pathologically by mediastenoscopy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

3-year survival

Key secondary outcomes

the rate of complete resection
pathological response of preoperative therapy(down staging, pathological CR)
Progression free survival
toxicities


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

Two courses of chemotherapy with cisplatin (40 mg m-2) and docetaxel (40 mg m-2) with 3 weeks interval is planned. A total radiation dose of 40 Gy is planned with conventional fractionation (2 Gy day-). Patients undergo surgery 3 to 4 weeks after the end of second course of chemotherapy.

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


Not applicable

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

a) Pathological diagnosis of non-small cell lung cancer is necessary. Lesions should be surgically respectable.
b) Age = or < 70 years
c) No prior treatment for lung cancer
d) stage IIIA or IIIB with pathologically-proved mediastinal lymph node. Patients with mediastinal LN of shortest diameter of larger than 1 cm, T2-4, or CEA > 10ng/ml are required to undergo mediastinoscopy. Mediastinal lymph node biopsy should be done for bilateral #1-4, and #7.
e) Performance status (ECOG criteria) 0-1
f) Resection index should be more than 30.
g) No other primary cancers within past 5 years and no active cancers
h) Adequate bone marrow function
WBC more than 4000/ul, Granulocyte more than 2000/ul, Hg more than 10.0g/dl, Platelet count more than 100,000/ul.
i) Adequate liver function
(T.Bil less than 1.5mg/dl, AST/ALT less than 2.5 times of normal range.)
j) Adequate renal level. (serum creatinin less than 1.5mg/dl, Creatinine clearlance more than 60mg/dl)
k) Adequate pulmonary function
(PaO2 more than 70torr)
l) No other severe complications. Agreement for the protocol by physicians, surgeons and radiologists is essential.
m) Written informed consent to participate in the trial is necessary

Key exclusion criteria

a) Malignant pleuritis or malignant pericarditis.
b) Pleural dissemination.
c) Positive suplra calavicle nodes.
d) Active double cancer. The definition of inactive is that disease-free interval is more than 5 years. However, patients who have history of chemotherapy or thoracic irradiation are not acceptable.
e) Patients with severe complications.
1) Pulmonary fibrosis recognized with computed tomography scanning.
2)Severe heart disease.(Uncontrollable angina or myocardial infarction within the past 3 months)
3) Uncontrollable Diabetes Mellitus.
4) Severe infectious disease
5) Other unsuitable patient judged by a physician.
f) Women during pregnancy or lactating.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Shinichi
Middle name
Last name Toyooka

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Department of Thoracic, Breast and Endocrine Surgery

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan

TEL

086-235-7265

Email

toyooka@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name Hiromasa
Middle name
Last name Yamamoto

Organization

Okayama University Hospital

Division name

Department of Thoracic Surgery

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan

TEL

086-235-7265

Homepage URL


Email

h.yamamoto@md.okayama-u.ac.jp


Sponsor or person

Institute

Setouchi Lung Cancer Group

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee

Address

2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan

Tel

086-235-6938

Email

mae6605@adm.okayama-u.ac.jp


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



Other administrative information

Date of disclosure of the study information

2007 Year 02 Month 08 Day


Related information

URL releasing protocol

N/A

Publication of results

Unpublished


Result

URL related to results and publications

N/A

Number of participants that the trial has enrolled

1

Results

Unpublished

Results date posted

2019 Year 08 Month 22 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Unpublished

Participant flow

Unpublished

Adverse events

Unpublished

Outcome measures

Unpublished

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2007 Year 01 Month 20 Day

Date of IRB

2010 Year 10 Month 25 Day

Anticipated trial start date

2007 Year 01 Month 01 Day

Last follow-up date

2011 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2007 Year 02 Month 07 Day

Last modified on

2019 Year 08 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000697


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name