Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorecta… (NCT03965234) | Clinical Trial Compass
RecruitingPhase 1/2
Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases
United States99 participantsStarted 2020-07-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Tumors metastatic to the lungs that are the focus of this protocol specifically:
* Soft tissue sarcoma
* Osteosarcoma
* Colorectal carcinoma
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
* Hemoglobin \> 8.0 g/L
* Granulocytes \> 1,500 uL
* Platelets \>= 100,000 uL
* Creatinine clearance \>= 30 mL/min
* Clinically diagnosed resectable sarcoma 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 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
* Forced expiratory volume in 1 second (FEV1) \>= 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 is technically feasible
* Borg Dyspnea scale (modified) \< 5
* Control of the pr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of local toxicities (Phase I)
Timeframe: Up to 2 years
2
Recommended phase II dose (Phase I)
Timeframe: Up to 5 years
3
Local recurrence (Phase II)
Timeframe: From resection until local recurrence in the suffused lung or last clinic follow-up, assessed up to 2 years