resectable pulmonary metastases of colorectal carcinoma, soft tissue sarcoma and osteosarcoma
Conditions
Interventions
Trade Name: Alkeran
Pharmaceutical Form: Intravenous infusion
Sponsors
St. Antonius Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 yrs and older Cytologic/histologic proof or high clinical probability of pulmonary metastases of colorectal carcinoma, soft tissue sarcoma or osteosarcoma No other systemic metastases present Primary site has been radically treated without signs of recurrence Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy or lactation Severe comorbility Previous thoracotomy or pleural pulmonary diseases resulting in obliteration of the pleural space
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine time to progression of the primary malignancy (locally advanced or metastatic) in patients treated with isolated lung perfusionwith mephalan followed by pulmonary metastatectomy.;Secondary Objective: To determine pulmonary toxicity by pulmonary function testing due to melphalan using ILuP and pulmonary metastatectomy To determine overall survival in patients treated with ILuP with melphalan using ILuP followed by pulmonary metastatectomy To determine mephalan concentrations in lung and tumortissue, systemic arterial circulation, perfusate, pleural effusions and bronchial lavage and perform population pharmacokinetic analyses To assess pulmonary intravascular volume by using computed tomography and per-operative dilution method;Primary end point(s): Time to prgresiion or disease free interval | — |
Countries
Netherlands
Outcome results
None listed