Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities (NCT04220229) | Clinical Trial Compass
TerminatedPhase 1/2
Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities
Stopped: Terminated due to end of funding
United States6 participantsStarted 2020-06-01
Plain-language summary
This phase I/II trial studies the side effects and best dose of cabozantinib when given with radiation therapy and how well it works in treating patients with sarcoma of the extremities. Cabozantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cabozantinib with radiation therapy may make the tumors smaller and reduce the amount of normal tissue that needs to be removed.
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:
* Subjects, \>= 18 years old, must have a histologically confirmed diagnosis of sarcomas of the extremities (which may include gluteal muscle involvement) for which neoadjuvant radiation therapy followed by surgical resection is a planned intervention
* Subjects whose bowel cannot be completely protected from radiation exposure due to primary tumor location (e.g., proximal lower extremity) will be excluded
* Subjects must have one or more measurable target lesions by RECIST version (v) 1.1, assessed via computed tomography (CT) scan or magnetic resonance imaging (MRI)
* At the time of study enrollment, subjects must have a tumor burden that is judged to be surgically resectable
* Absolute neutrophil count (ANC) \>= 1500/mm\^3 (\>= 1.5 GI/L) without granulocyte colony-stimulating factor support in the last 28 days
* White blood cell count \>= 2500/mm\^3 (\>= 2.5 GI/L)
* Platelets \>= 100,000/mm\^3 (\>=100 GI/L) without transfusion in the last 28 days
* Hemoglobin \>= 9 g/dL (\>= 90 g/L) without transfusion in the last 28 days
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =\< 3 X upper limit of normal (ULN)
* Alkaline phosphatase (ALP) =\< 3 X upper limit of normal (ULN)
* ALP =\< 5 X ULN is permitted in subjects with documented bone metastases (phase 1 only)
* Total bilirubin =\< 1.5 x ULN (for subjects with Gilbert's disease =\< 3 X ULN)
* Serum albumin \>= 2.8 g/dl
* Serum creatinine =\< 2.0 x ULN or calculated creatinine clear…
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
Recommended Phase 2 Dose of Cabozantinib S-malate (Cabozantinib) (Phase I)
Timeframe: Up to 21 days
2
Rate of Relapse (Phase II)
Timeframe: At 12 months after treatment initiation