Actively Recruiting
In Vivo Lung Perfusion as Adjuvant Treatment During Surgery for Pulmonary Metastases of Bone and Soft Tissue Sarcomas
Led by University Health Network, Toronto · Updated on 2025-11-26
17
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new way to treat sarcoma that has spread to the lungs by delivering chemotherapy directly into the lungs during surgery. This approach, called In Vivo Lung Perfusion (IVLP), aims to kill tiny cancer cells in the lungs that cannot be seen or detected with current methods. This Phase I, non-randomized, dose escalation study serves as a pilot for a larger trial and focuses on patients with bilateral lung metastases from bone or soft tissue sarcoma. Participants will undergo surgery using a posterolateral thoracotomy to access the lungs. During surgery, one lung will receive IVLP with doxorubicin chemotherapy at varying doses (5, 7, or 9 mcg/ml) for three hours, followed by removal of lung metastases. The other lung will be treated with the current standard care, either surgery or radiation, serving as a control. An expansion group will receive the ideal dose determined from initial dosing. Post-surgery care will follow institutional standards. Participants will be followed for up to two years to monitor safety and measure the maximum tolerated dose through signs of acute lung injury. Researchers will also evaluate additional safety outcomes and treatment effects. Throughout the study, patients will have surgeries, assessments, and follow-up visits as per the study schedule to closely monitor their health and response to the treatment.
CONDITIONS
Brief Title
In Vivo Lung Perfusion for Pulmonary Metastases of Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Soft Tissue or Osteogenic Sarcoma
- Presence of bilateral pulmonary metastases
- 3 or more lung lesions in total
- Age less than 65 years
- ECOG performance status 0-2
- No disease outside the lungs
- Contralateral lung disease treatable by surgery or radiation
- Lung lesions in the treated lung can be removed by wedge or segmental resections
- Non-IVLP lung treated with surgery or radiation 4-12 weeks before IVLP
You will not qualify if you...
- Previous doxorubicin dose over 450 mg
- Left ventricular ejection fraction below 50%
- History of significant lung disease or pneumonitis
- Pregnant or breastfeeding females
- Age below 18 years or 65 years and older
- Unable to understand informed consent
- Allergy to doxorubicin
- Currently in another therapeutic clinical trial
- Previous lung metastasectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo surgical resection of pulmonary metastases combined with in vivo lung perfusion of doxorubicin as adjuvant treatment.
1 surgical visit and hospital stay
Duration - Up to 2 years
Participants are monitored for safety and treatment effects after surgery and lung perfusion.
Regular follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Canada
Actively Recruiting
Research Team
M
Marcelo Cypel, M.D.
J
Jennifer Lister, BSc CCRP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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