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

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 - not applicable

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37141

Enrollment

Registered

2006-12-29

Start date

2006-06-07

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

secundary cancer of the lung. The spread of a malignant tumour to the lung(s)

Interventions

Isolated lung perfusion with melphalan followed by pulmonary metastasectomy

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - pregnancy/lactation - uncontrollable infectious disease - previous thoracotomy

Design outcomes

Primary

Measure	Time frame
Time to progression or disease-free interval	—

Secondary

Measure	Time frame
-Any CTC (common toxicity criteria according to National Cancer Institute) grade 3 or more hematologic or non-hematologic toxicity with possible or probable relation to the procedure at any time point except for pulmonary toxicity, grade 4 pulmonary toxicity or any radiographic change of the perfused lung resembling a chemical pneumonitis involving the whole lung, or any CTC grade 3 or more pulmonary toxicity on day 90. -Overall survival. -Lung, tumour tissue and perfusate concentrations in relation to time to progression and toxicity -Population pharmacokinetic parameters of melphalan using ILuP	—

Measure

Time frame

-Any CTC (common toxicity criteria according to National Cancer Institute) grade 3 or more hematologic or non-hematologic toxicity with possible or probable relation to the procedure at any time point except for pulmonary toxicity, grade 4 pulmonary toxicity or any radiographic change of the perfused lung resembling a chemical pneumonitis involving the whole lung, or any CTC grade 3 or more pulmonary toxicity on day 90. -Overall survival. -Lung, tumour tissue and perfusate concentrations in relation to time to progression and toxicity -Population pharmacokinetic parameters of melphalan using ILuP

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)