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NCT03965234 · ClinicalTrials.gov record · last posted 2026-08-21

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

StatusRecruiting
PhasePhase 1/2
Started2020-07-16
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from the ClinicalTrials.gov record
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.

Protocol amendment history 1 change detected by DataLookout

2026-08-22
Primary endpoint(s) modified
WasIncidence of local toxicities (Phase I), Local recurrence (Phase II), Recommended phase II dose (Phase I)
NowIncidence of local and systemic toxicities (Phase II), Incidence of local toxicities (Phase I), Local recurrence (Phase II), Recommended phase II dose (Phase I)
Trial Details
NCT Number NCT03965234
Lead Sponsor Roswell Park Cancer Institute
Conditions Metastatic Bone Sarcoma, Metastatic Malignant Neoplasm in the Lung, Metastatic Soft Tissue Sarcoma, Metastatic Unresectable Sarcoma, Resectable Sarcoma, Colorectal Cancer
Enrollment 99 participants
Start Date 2020-07-16
Primary Completion 2029-05-25 (estimated)
Study Completion 2030-05-25 (estimated)
Updated on ClinicalTrials.gov 2026-08-21