Lung-Directed chemo spray aims to stop cancer spread
NCT ID NCT03965234
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 3 times
Summary
This study tests a procedure called pulmonary suffusion, which delivers the chemotherapy drug cisplatin directly to the lungs through a minimally invasive method. The goal is to control any remaining cancer cells after surgery or ablation in patients with sarcoma or colorectal cancer that has spread to the lungs. About 99 adults with resectable or ablatable lung metastases are being enrolled to evaluate safety and effectiveness.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 99 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2020
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Roswell Park Cancer Institute
RECRUITINGBuffalo, New York, 14263, United States
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