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)
Conditions
Interventions
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 (sarc
Sponsors
University of Miyazaki Hospital Department of Surgery II
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTakanori AYABE
University of Miyazaki Faculty of Medicine Department of Surgery II
Outcome results
None listed