A phase II study of isolated lung perfusion with melphalan followed by pulmonary metastatectomy in patients with resectable pulmonary metastases of colorectal carcinoma, soft tissue sarcoma and osteosarcoma - ILUP-II

• Conditions: resectable pulmonary metastases of colorectal carcinoma, soft tissue sarcoma and osteosarcoma

• Registration Number: EUCTR2006-002808-34-NL
• Lead Sponsor: St. Antonius Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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

Pregnancy or lactation
Severe comorbility
Previous thoracotomy or pleural pulmonary diseases resulting in obliteration of the pleural space

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>To determine overall survival in patients treated with ILuP with melphalan using ILuP followed by pulmonary metastatectomy<br>To determine mephalan concentrations in lung and tumortissue, systemic arterial circulation, perfusate, pleural effusions and bronchial lavage and perform population pharmacokinetic analyses<br>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