Using pulmonary suffusion to control minimal residual disease in sarcoma and colorectal cancer patients
Official title: Phase I/ II Study of Pulmonary Suffusion to Control Minimal Residual Disease in Resectable or Ablatable Sarcoma or Colorectal Pulmonary Metastases
Run by Roswell Park Cancer Institute · NCT03965234 · Data updated 2026-11-12
This study is testing a new way to deliver chemotherapy directly to the lungs in patients with sarcoma or colorectal cancer that has spread there, to see if it helps control the disease better and is safe to use.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 99 (estimated) |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Buffalo, New York) |
| Status | Recruiting |
| Started | July 16, 2020 |
| Main results expected | May 25, 2029 |
| Study ends | May 25, 2030 |
| Registry record updated | August 21, 2026 |
| Trial ID | NCT03965234 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with resectable lung metastases from soft tissue sarcoma, osteosarcoma, or colorectal carcinoma who meet specific health criteria.
✕Probably not a fit
Patients with non-resectable lung metastases or those with poor performance status 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 clinical trial evaluates the safety and effectiveness of pulmonary suffusion, a minimally invasive method for delivering chemotherapy directly to lung tissues, in patients with sarcoma or colorectal cancer that has metastasized to the lungs. The study aims to determine the maximum tolerated dose of chemotherapy agents like cisplatin and assess local recurrence rates compared to historical controls. Secondary objectives include evaluating local and systemic toxicities, disease-free survival, and overall survival rates. The trial also explores changes in the tumor microenvironment and potential immune modulation effects associated with pulmonary suffusion.
Why it matters
Potential benefit: If successful, this approach could provide a targeted treatment option that minimizes systemic side effects while effectively controlling metastatic disease in the lungs.
How similar studies have gone: While the specific approach of pulmonary suffusion is novel, similar localized chemotherapy methods have shown promise in other studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Tumors metastatic to the lungs that are the focus of this protocol specifically: * Colorectal carcinoma * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Hemoglobin \> 8.0 g/L * Neutrophils \> 1,500 uL * Platelets \>= 100,000 uL * Creatinine clearance \>= 30 mL/min * Clinically diagnosed lung metastases(while preregistration histologic or cytologic confirmation is desirable, this may not be required in clinical scenarios where a biopsy may not change the need to resect suspicious lung nodules or the biopsy itself poses a risk for tumor seeding. In such cases, the diagnosis will be supported by rapid pathologic evaluations intraoperatively before proceeding with Suffusion) Given the emergence of other acceptable options to destroy lung metastases such as stereotactic body radiation therapy (SBRT) or microwave ablation, a hybrid approach to eliminate all sites of disease will be permitted; however, supplemental approaches should be delayed, if possible, until after the 30 day post-suffusion endpoint * Pulmonary function judged by the surgeon to be sufficient to tolerate the planned pulmonary metastasectomy. Testing is not required but generally is performed clinically and will be left to the discretion of the treating surgeon. The following are not required but serve as guidelines since they were used to determine eligibility for the Phase I protocol: EV1 \>= 50% predicted * Diffusion capacity of the lung for carbon monoxide (DLCO) \>= 50% predicted * Vital capacity (VC) \>= 50% predicted * Ambulatory and resting oxygen (O2) saturation \> 88% * Six minute walk \>= 50 % of the expected distance * Surgeon affirmation that suffusion and resection or ablation of all nodules is technically feasible * Control of the primary tumor as determined by clinical assessment per standard of care; may include stable tumor status of primary tumor and other metastases, in the clinical judgement of the PI/consulting physician. * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events * Allergy, intolerance, or other serious reaction to chemotherapy drugs that may be used in the procedure * Pregnant or nursing female participants * Unwilling or unable to follow protocol requirements * Pulmonary metastases unable to be completely resected or ablated based on pre-registration review of imaging by a thoracic surgeon or proceduralist. * Any additional condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug or the suffusion technique, may include uncontrolled intercurrent illness and other conditions that, in the judgement of the PI/Physician, would limit compliance with the study requirements and have safety concerns * Received an investigational agent within 30 days prior to enrollment * Severe peripheral neuropathy
Where it's running
-
Roswell Park Cancer Institute
Buffalo, New York, United States Recruiting
Study contacts
- Principal investigator: Kenneth Seastedt — Roswell Park Cancer Institute
- Study coordinator: Kenneth Seastedt
- Email: Kenneth.Seastedt@Roswellpark.org
- Phone: 716-845-2300
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Knife-assisted full-thickness resection for rectal lesions in a multicenter setting
A multicenter study tests knife-assisted full-thickness resection (kFTR) to remove rectal lesions in adults and see how well it works and how safe it is.
-
Personalized 3D Bioprinted Colorectal Cancer Microenvironment Model
This study tests patient-derived, 3D-bioprinted cancer models that include tumor, fibroblast, and immune cells to see if they can better predict how colorectal cancer will respond to treatment.
-
Integrated genomic and clinical database for cancer biomarker discovery
Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.
-
Prehabilitation with Resistance, Aerobic, or Both Before Colorectal Surgery
Four pre-surgery exercise options (resistance, aerobic, both, or none) will be tested to see which best reduces complications after colorectal cancer surgery.
-
Liver transplantation for colorectal cancer with liver metastases
This study follows adults with stage IV colorectal cancer whose disease is limited to the liver and who are getting a liver transplant as part of their cancer care to see how they fare over time.
-
LTZ-232: a first-in-human test in advanced colorectal and other solid tumors
A first-in-human study tests LTZ-232, a new therapy for adults with unresectable or metastatic colorectal cancer and other solid tumors that have not responded to standard treatments.
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.