A phase II study of isolated lung perfusion with melphalan followed by pulmonary metastasectomy in patients with resectable pulmonary metastases of colorectal carcinoma, soft tissue sarcoma and osteosarcoma
Phase 2
Completed
- Conditions
- secundary cancer of the lung.The spread of a malignant tumour to the lung(s)10027476
- Registration Number
- NL-OMON37141
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 65
Inclusion Criteria
-18 years or older
-histologic proof or strong clinical suspicion of a pulmonary metastases with colorectal carcinoma and sarcoma
-no other sites of metastases
-radicallly treated primary colorectal carcinoma/sarcoma
-no more than 10 pulmonary metastases
-no significant other co-morbidity
Exclusion Criteria
- pregnancy/lactation
- uncontrollable infectious disease
- previous thoracotomy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Time to progression or disease-free interval</p><br>
- Secondary Outcome Measures
Name Time Method <p>-Any CTC (common toxicity criteria according to National Cancer Institute)<br /><br>grade 3 or more hematologic or non-hematologic toxicity with possible or<br /><br>probable relation to the procedure at any time point except for pulmonary<br /><br>toxicity, grade 4 pulmonary toxicity or any radiographic change of the perfused<br /><br>lung resembling a chemical pneumonitis involving the whole lung, or any CTC<br /><br>grade 3 or more pulmonary toxicity on day 90.<br /><br><br /><br>-Overall survival.<br /><br><br /><br>-Lung, tumour tissue and perfusate concentrations in relation to time to<br /><br>progression and toxicity<br /><br><br /><br>-Population pharmacokinetic parameters of melphalan using ILuP</p><br>