isolated lung perfusion with melphalan followed by pulmonary metastasectomy in patients with resectable pulmonary metastases of colorectal carcinoma, soft tissue sarcoma and osteosarcoma

• Conditions: G METASTASIS FROM COLON RECTAL CARCINOMA, SOFT TISSUE SARCOMA AND OSTEOSARCOMA; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-002808-34-IT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-27
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Age of 18 years and older.
Patients with pulmonary metastases from colorectal carcinoma, sarcomas of soft tissue and osteosarcomas
Patients with pulmonary metastases from colorectal carcinoma, sarcomas of soft tissue and osteosarcomas

?Cytologic/histologic proof or high clinical probability of pulmonary metastases of colorectal carcinoma, soft tissue sarcoma or osteosarcoma

?No other systemic metastases present than pulmonary metastases

?Primary site has been radically treated without signs of recurrence

?Patient is a candidate for pulmonary metastasectomy with no more than 10 pulmonary metastases documented on CT scan of the thorax. Metastases must be located primarily in the periphery of the lungs.

?No standard treatment options available, except pulmonary metastasectomy

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 2
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

Pregnancy/lactation

?Uncontrollable infectious disease

?Liver/renal insufficiency; serum creatinine more than 130 µmol/l and urine creatinine clearance less than 60 ml/min, ALAT and ASAT more than 3 times normal.

?Severe comorbidity

?Previous thoracotomy or pleuropulmonary diseases resulting in obliteration of the pleural space

Study & Design

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