UMIN-CTR Clinical Trial

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	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 (OLCSG1601)
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)
Scientific Title:Acronym	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 (OLCSG1601)
Region	Japan

Condition
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	NO

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	NO
Concealment	Central registration

Intervention
No. of arms	2
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	80

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
Institute	Okayama Lung Cancer Study Group (OLCSG)
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028556