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
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
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
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
