UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000024816
Receipt number	R000028556
Scientific Title	A randomized phase II study comparing cisplatin + docetaxel with carboplatin + paclitaxel in patients with Stage III (N 2 positive) non-small-cell lung cancer who receive trimodality treatment consisting of chemoradiotherapy followed by surgery (OLCSG1601)
Date of disclosure of the study information	2016/12/21
Last modified on	2020/05/17 14:43:17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information

Public title

A randomized phase II study comparing cisplatin + docetaxel with carboplatin + paclitaxel in patients with Stage III (N 2 positive) non-small-cell lung cancer who receive trimodality treatment consisting of chemoradiotherapy followed by surgery (OLCSG1601)

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

previously untreated non-small-cell lung ccancer, stage III (N2 positive)

Classification by specialty

Pneumology Chest surgery Radiology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

This study is aimed to examine the effectiveness and safety of trimodality therapy consisting of chemoradiotherapy followed by surgery, and search for the optimal regimen in this trimodaryt treatment by comparing 'Cisplatin and Docetaxel' with 'Carboplatin and Paclitaxel'.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Assessment

Primary outcomes

2 year progression free survival rate

Key secondary outcomes

Response rate of preoperative treatment, progression-free survival, 2-year survival rate, overall survival time, curative resection rate of surgery, completion rate of protocol treatment , adverse event

Base

Study type

Interventional

Study design

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

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Group A: Chemoradiotherapy consiting of Cisplatin and Docetaxel before surgery. Surgical resection is performed within 4 to 8 weeks after chemoradiotherapy is completed. After that, within 4 to 8 weeks, add 2 courses of chemotherapy (Cisplatin and Docetaxel) and finish the schedule treatment.

Interventions/Control_2

Group B: Chemoradiotherapy consiting of Carboplatin, Paclitaxel before surgery. Surgical resection is performed within 4 to 8 weeks after chemoradiotherapy is completed. After that, within 4 to 8 weeks, add 2 courses of chemotherapy (Carboplatin and Paclitaxel) and finish the schedule treatment.

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

(1) A case of non-small-cell lung cancer who proved pathologically (by histology or cytology). and seemed to be completely resectable.
(2) Age is over 20 years old and under 75 years old.
(3) A case of the first treatment.
(4) A case of stage III whose metastasis to ipsilateral mediastinum and / or tracheal bifurcation lymph nodes was proved by longitudinal mediastinoscope or ultrasonic bronchoscope guided needle biopsy (EBUS - TBNA) etc. However, no pathological proof is required for #5 and 6 lymph nodes, if PET-CT is positive. The stage is evaluated by CT, MRI, PET-CT, etc.
(5) A case whose ECOG Performance status (PS) is 0 - 1.
(6) A case in which a three-dimensional radiation treatment plan is performed before registration and the treatment plan that V20 is 35% or less and radiation therapists comply with this protocol radiation treatment regulation is possible.
(7) No case of other primary cancers within the past 5 years, and no active double cancer.
(8) A Case with measurable lesions based on RECIST v 1.1.
(9) A Case whose major organ function satisfies all of the following.
White blood cell count > 4,000 / mm3, neutrophil count > 2,000 / mm3
Platelet count > 10,000 / mm3
Hemoglobin > 10.0 g / dL
Serum AST and ALT: 2.5 times or less the upper limit of reference value of each facility
Serum total bilirubin: 1.5 times or less the upper limit of reference value of each facility
Serum creatinine < 1.5 mg / dL, CCr > 60 ml / min
SpO2 > 92% in in room air (if SpO2 <92%, it is eligible if PaO2 > 70 Torr)
forced expiratory volume in one second > 1.5 L / min
(10) A case without any other serious complications, other physicians, surgeons and radiologists have agreed to implement the protocol.
(11) A case judged to be able to survive for 3 months or more from the date of registration.
(12) A case in which the subject consent has been obtained from the subject himself / herself.

Key exclusion criteria

(1) A case who has active double cancer.
Even in case of metachronous double cancer (more than 5 years), patient with a history of chemotherapy or chest radiotherapy is excluded.
(2) A case with severe drug allergy history.
(3) Pregnant / lactating woman, a woman with an intention of pregnancy, a man with a partner who has an intention of pregnancy.
(4) A case with severe complications such as the following.
Active interstitial lung disease in chest X ray and CT
Serious heart disease (difficult to control angina, myocardial infarction within 3 months, etc.)
Diabetes mellitus difficult to control
Serious infection
Active hepatitis B, hepatitis C
Other complications that are thought to have serious obstacles to the performance of treatment
(5) A case with peripheral sensory neuropathy or peripheral motor neuropathy of more than grade 2.
(6) A case that the doctor judged inappropriate.

Target sample size

Research contact person

Name of lead principal investigator

1st name Katsuyuki

Middle name

Last name Kiura

Organization

Okayama University Hospital

Division name

Department of Allergy and Respiratory Medicine

Zip code

7008558

Address

2-5-1, Shikata cho, Kita Ku, Okayama city, Okayama prefecture

TEL

086-235-7227

Email

kkiura@md.okayama-u.ac.jp

Public contact

Name of contact person

1st name Toshio

Middle name

Last name Kubo

Organization

Okayama University Hospital

Division name

Center for oncology

Zip code

7008558

Address

2-5-1, Shikata cho, Kita Ku, Okayama city, Okayama prefecture

TEL

086-235-7227

Homepage URL

Email

t-kubo@cc.okayama-u.ac.jp

Sponsor or person

Institute

Okayama Lung Cancer Study Group (OLCSG)

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 hospital

Address

2-5-1, Shikata cho, Kita Ku, Okayama city, Okayama prefecture

Tel

086-235-6503

Email

mae6605@adm.okayama-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 21 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

Terminated

Date of protocol fixation

2016 Year 12 Month 20 Day

Date of IRB

2016 Year 12 Month 20 Day

Anticipated trial start date

2016 Year 12 Month 21 Day

Last follow-up date

2019 Year 03 Month 24 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2016 Year 11 Month 13 Day

Last modified on

2020 Year 05 Month 17 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028556