New method to deliver chemotherapy directly into the lungs for sarcoma patients
Official title: In Vivo Lung Perfusion (IVLP) as an Adjuvant Treatment for Patients Undergoing Surgical Resection of Pulmonary Metastases of Bone and Soft Tissues Sarcomas
Run by University Health Network, Toronto · NCT02811523 · Data updated 2026-11-12
This study is testing a new way to deliver chemotherapy directly into the lungs during surgery for sarcoma patients to see if it can better target hidden cancer cells and improve their outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 0 Years to 64 Years |
| Sex | All |
| Enrollment | 17 (estimated) |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation, doxorubicin, chemotherapy |
| Locations | 1 site (Toronto) |
| Status | Recruiting |
| Started | February 2016 |
| Main results expected | September 2030 |
| Study ends | September 2030 |
| Registry record updated | November 26, 2025 |
| Trial ID | NCT02811523 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients under 65 years old with bilateral pulmonary metastases from soft tissue or osteogenic sarcoma and multiple lung lesions.
✕Probably not a fit
Patients over 65 years old, those with significant pulmonary disease, or those who have previously received high doses of doxorubicin may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates a novel technique called In Vivo Lung Perfusion (IVLP) to deliver chemotherapy directly into the lungs during surgery for patients with sarcoma that has spread to the lungs. The goal is to target microscopic cancer cells that may remain undetected at the time of surgery, potentially improving patient outcomes. This Phase I, non-randomized, dose escalation study will serve as a pilot for future larger studies. The intervention involves administering doxorubicin directly into the lungs to minimize side effects on other organs.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with pulmonary metastases from sarcoma.
How similar studies have gone: While this approach is novel, similar targeted delivery methods in other cancers have shown promise, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 0-2 * Absence of extra-pulmonary disease * Contralateral disease amenable to surgery or radiation * All lung lesions in the lung to be treated with IVLP can be resected with wedge or segmental resections (non-IVLP treated lung will be treated with radiation or surgery 4-12 weeks prior to IVLP) Exclusion Criteria: * Patient has previously received more than 450 mg of doxorubicin * Left Ventricular Ejection Fraction \<50% * History of significant pulmonary disease or pneumonitis * Pregnant or lactating females * Age 65 years or older, or less than 18 years * Inability to understand the informed consent process * Hypersenstivity to doxorubicin * Current participation in another therapeutic clinical trial * Previous lung metastatectomy
Where it's running
-
Princess Margaret Cancer Centre
Toronto, Canada Recruiting
Study contacts
- Principal investigator: Marcelo Cypel, MD — University Health Network, Toronto
- Study coordinator: Marcelo Cypel, M.D.
- Email: marcelo.cypel@uhn.ca
- Phone: 416-581-7773
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Preoperative Immunonutrition for bone and soft tissue sarcoma patients
This study tests whether a short course of an oral nutrition supplement before surgery can help patients with bone or soft tissue sarcomas recover better after major tumor-related surgery.
-
Using a special dye to guide surgery for sarcoma removal
This study is testing whether a special dye can help surgeons remove sarcomas more accurately by showing them where the cancer ends during surgery.
-
Assessing early psychiatric referral effects on mental health in sarcoma patients
This study tests whether getting early mental health support helps sarcoma patients feel less anxious and depressed while recovering from surgery.
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Evaluating quality of life and functional outcomes in sarcoma patients after limb salvage surgery
This study looks at how limb salvage surgery affects the quality of life and daily functioning of people aged 18 to 95 who have had surgery for bone or soft tissue sarcoma in their legs.
-
Quality assessment of sarcoma care in Europe and Latin America
This study looks at how well patients with different types of sarcoma are treated in Europe and Latin America to see if care is better at expert centers and to find ways to improve outcomes.
-
68Ga-HX01 PET/CT Imaging in Soft Tissue Sarcoma patients
This study tests whether a 68Ga-HX01 injection can help PET/CT imaging better characterize soft tissue sarcoma in adults who have exhausted standard treatments or have no good options.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.