Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 and up

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

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment99 (estimated)
SponsorRoswell Park Cancer Institute
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Buffalo, New York)
StatusRecruiting
StartedJuly 16, 2020
Main results expectedMay 25, 2029
Study endsMay 25, 2030
Registry record updatedAugust 21, 2026
Trial IDNCT03965234 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.