UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial on Efficacy and Safety of the Next-generated intrapleural hyperthermic chemotherapy for thoracic malignancies with dissemination and malignant pleural effusions
Title of the study (Brief title)	Phase II study of next-generated intrapleural hyperthermic chemotherapy for thoracic malignancies
Region	Japan

Condition
Condition	Thoracic malignancies with dissemination and carcinomatous pleuritis and malignant pleural effusions (unresected advanced lung cancer, postoperative intrathoracic recurrence, malignant pleural mesothelioma, intrathoracic metastasis due to breast and colon cancers, and the other malignant diseases)
Classification by specialty	Pneumology Hematology and clinical oncology Surgery in general Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Feasibility study of next-generated intrapleural hyperthermic chemotherapy for thoracic malignancies. Phase II study of efficacy and safety on regimens of Cisplatin/S-1, Cisplatin/Pemetrexed, and hypotonic lavage and Cisplatin tereatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	1)Efficacy(response rate of local tumor) 2)Control rate of malignant pleural effusions 3)Pathological assessment 4)Cytology of drainaged pleural effusions 5)Monitoring of Intrathoracic temperature 6)Analysis of free-radical productives (oxidative stress and anti-oxidative capacity 7)Time to treatment failure (TTF) 8)Changes of quality of life 9)Chest Drain-free Survival 10)Sympton-related Progression-free survival 11)Changes of pulmonary function test
Key secondary outcomes	1)Safety, adverse event (NCI-CTCAE, ver 4.0) 2)intraoperative, postoperative complications (NCI-CTCAE ver 4.0) 3)Overall Survival 4)Progression-free survival 5)postoperative thoracic drainaged fluid amounts 6)postoperative thoracic drainaged duration 7)post-treatments

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 Device,equipment
Interventions/Control_1	1)S-1 + CDDP treatemnt for non-small cell lung cancer 2)Pemetrexed + CDDP treatment for malignant pleural mesothelioma 3)Hypotonic lavage and CDDP treatment for the other thoracic malignancies (sarcomas, metastases, thymomas, etc.)
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Non-small lung cancer, malignant pleural mesothelioma, thoracic malignancies diagnoged with by pathological and/or cytological examination 2)available for pretreatment, posttreatment, and non-treatment status such as surgery, irradiation, chemotherapy, and molecular-targeted agent therapy. Over 2 weeks after palliative irradiation for bone metastasis and gamma-knife except primary malignancies 3)clinical staged IIIB/IV or postoperative recurrence, either indicated or not for definitive irradiation 4)no complication of viable double cancers 5)<= 80 years-old (on informed consent) 6)Performance status 0-1(Eastern Cooperative Oncology Group) 7)Spirometry (FEV1 > 600ml/m2) 8)Organ function before 2 weeks WBC >=4,000 /mm3, Hemoglobin >=9.0 g/dl(by blood transfusion), Platelet >= 100,000 /mm3 (by blood transfusion), AST <= 100 IU/L, ALT <=100 IU/L, Total-bil<= 1.5 mg/dl, Serum creatinin <= 1.5 mg/dl(Ccr>= 45ml/min), Urine protein <=1+, arterial blood gas >=60 Torr(or >=SpO2 90%) 9)RECIST v1.1 (New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) 10)malignant pleural effusions 11)pathological disseminated cases found on initial lung cancer surgery 12)Informed consent for intrapleural hyperthermic chemotherapy treatment (document) 13)expected survival >= 3 months 14)Informed consent for clinical trial (document) 15)based on the preoperative examination and on the above criteria from 1) to 14), available and bearable for general anesthesia, video-assisted thoracic surgery or open thoracotomy, and lobectomy.
Key exclusion criteria	1)symptomatic brain metastasis 2)the complications (hemoptysis >= 2.5ml of fresh blood, arterial thromboembolism (brain infarction, temporarily ischemic attack, myocardial infarction, angina pectoris), venous thoromboembolism (deep vein thromboembolism, pulmonary embolism), uncontrollable hypertension, intestinal perforation, severe fistula, broncho-esophageal fistula, intraabdominal inflammation, congenital bleeding tendency, abnormality of blood coagulation, uncontrollable diabetic mellitus, infection, active intestinal pneuminitis 3)surgery within 28 days (except for lung cancer) 4)scheduled thoracic irradiation during bevasizumab treatment 5)symptomatic cardiac tamponade 6)needs to receive an emergency irradiation due to supra vena cava syndrome 7)active pneumonia and intestinal pneumonitis displayed by chest X-ray/chest computed-tomographic examination 8)difficult to enroll because of complication with psychosomatic disease or mental symptomati problems 9)Others. Patients judged for inappropriation by attending physician or lead principal investigator
Target sample size	30

Research contact person
Name of lead principal investigator	Takanori AYABE
Organization	University of Miyazaki Faculty of Medicine
Division name	Department of Surgery II
Address	5200, Kiwara, Kiyotake, Miyazaki, Miyazaki, 889-1692, JAPAN
TEL	0985-85-2291
Email	tayabe@med.miyazaki-u.ac.jp

Public contact
Name of contact person	Takanori AYABE
Organization	University of Miyazaki Faculty of Medicine
Division name	Department of Surgery II
Address	5200, Kiwara, Kiyotake, Miyazaki, Miyazaki, 889-1692, JAPAN
TEL	0985-85-2291
Homepage URL
Email	tayabe@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki Hospital Department of Surgery II
Institute
Department

Funding Source
Organization	University of Miyazaki Hospital Clinical Trial Suport Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 10 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 17 Day
Anticipated trial start date	2014 Year 10 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 02 Month 04 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 05 Day
Last modified on	2019 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017841