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NCT03965234 · ClinicalTrials.gov registry record · Phase 1
Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases
A Phase 1 study of Colorectal Cancer and Metastatic Malignant Neoplasm in the Lung, sponsored by Roswell Park Cancer Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 99
- Enrollment target
- 1
- Study location
NCT03965234: Recruiting Phase 1 study of Colorectal Cancer and Metastatic Malignant Neoplasm in the Lung, sponsored by Roswell Park Cancer Institute.
NCT03965234 is a Phase 1 study of Colorectal Cancer and Metastatic Malignant Neoplasm in the Lung that is actively recruiting participants, run by Roswell Park Cancer Institute. The registered enrollment target is 99 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03965234, a Phase 1 study of Colorectal Cancer and Metastatic Malignant Neoplasm in the Lung, is actively recruiting participants, sponsored by Roswell Park Cancer Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 99 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Dose limiting toxicities (DLTs) will be defined based on the rate of drug-related grade 3-5 adverse events. These will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
Conditions Studied
Interventions
- DRUG Cisplatin
- PROCEDURE Isolated Chemotherapeutic Lung Perfusion
- PROCEDURE Metastasectomy
Study Locations (1)
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2020-07-16 |
| Est. Completion | 2030-05-25 |
| Phase | Phase 1 |
What NCT03965234 shows while recruiting
NCT03965234 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (94% lower).
The record links to 6 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Cisplatin is the first listed.
NCT03965234 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03965234 about?
NCT03965234 is a clinical study titled "Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases". 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....
What is the current status of trial NCT03965234?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 99 participants. The study started on 2020-07-16. Estimated completion is 2030-05-25.
What conditions does trial NCT03965234 study?
This clinical trial studies the following conditions: Colorectal Cancer, Metastatic Malignant Neoplasm in the Lung, Metastatic Soft Tissue Sarcoma, Resectable Sarcoma, Metastatic Bone Sarcoma.
What interventions are being tested in trial NCT03965234?
The interventions under investigation include: Cisplatin (DRUG), Isolated Chemotherapeutic Lung Perfusion (PROCEDURE), Metastasectomy (PROCEDURE).
Who is sponsoring clinical trial NCT03965234?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03965234 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03965234's enrollment target sits among peer trials
99 221st of 381 higher than 161 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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