UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015343
Receipt number R000017841
Scientific Title Clinical trial on Efficacy and Safety of the Next-generated intrapleural hyperthermic chemotherapy for thoracic malignancies with dissemination and malignant pleural effusions
Date of disclosure of the study information 2014/10/05
Last modified on 2019/02/04 14:48:51

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Basic information

Public title

Clinical trial on Efficacy and Safety of the Next-generated intrapleural hyperthermic chemotherapy for thoracic malignancies with dissemination and malignant pleural effusions

Acronym

Phase II study of next-generated intrapleural hyperthermic chemotherapy for thoracic malignancies

Scientific Title

Clinical trial on Efficacy and Safety of the Next-generated intrapleural hyperthermic chemotherapy for thoracic malignancies with dissemination and malignant pleural effusions

Scientific Title:Acronym

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

1st name
Middle name
Last name Takanori AYABE

Organization

University of Miyazaki
Faculty of Medicine

Division name

Department of Surgery II

Zip code


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

1st name
Middle name
Last name Takanori AYABE

Organization

University of Miyazaki Faculty of Medicine

Division name

Department of Surgery II

Zip code


Address

5200, Kiwara, Kiyotake, Miyazaki, Miyazaki, 889-1692, JAPAN

TEL

0985-85-2291

Homepage URL


Email

tayabe@med.miyazaki-u.ac.jp


Sponsor or person

Institute

University of Miyazaki Hospital
Department of Surgery II

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 05 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2014 Year 10 Month 17 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017841


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name