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NCT03965234RecruitingPhase 1/2

Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases

Phase I/ II Study of Pulmonary Suffusion to Control Minimal Residual Disease in Resectable or Ablatable Sarcoma or Colorectal Pulmonary Metastases

Source: ClinicalTrials.gov · Last updated 21 Aug 2026

Brief summary (registry, in English)

This phase I/II trial studies the side effects of pulmonary suffusion in controlling minimal residual disease in patients with sarcoma or colorectal carcinoma that has spread to the lungs. Pulmonary suffusion is a minimally invasive delivery of chemotherapeutic agents like cisplatin to lung tissues. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pulmonary suffusion may also be useful in avoiding later use of drugs by vein that demonstrate no effect on tumors when delivered locally. The Phase 1 portion of the study has been completed.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
99 (estimated)
First submitted
22 May 2019
Start date
16 Jul 2020
Primary completion date
25 May 2029
Lead sponsor
Roswell Park Cancer Institute
NCT number
NCT03965234

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 99
  • From 16 Jul 2020 to the primary completion date, 25 May 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Received an investigational agent within 30 days prior to enrollment

Other illness

  • Allergy, intolerance, or other serious reaction to chemotherapy drugs that may be used in the procedure
  • 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

Other

  • 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
  • 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.
  • Severe peripheral neuropathy

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Roswell Park Cancer Institute
Coordinator of this site? Confirm its status
BuffaloUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.