Systemic Therapy With or Without Local Consolidative Therapy in Treating Patients With Oligometas… (NCT03599765) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Systemic Therapy With or Without Local Consolidative Therapy in Treating Patients With Oligometastatic Solid Tumor
United States380 participantsStarted 2018-07-31
Plain-language summary
This phase II trial studies how well systemic therapy with or without local consolidative therapy work in treating patients with solid tumor that has spread to 1 site of other places in the body. Treatment with up-front local consolidative therapy may be better in helping to control the disease.
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:
* Oligometastatic solid tumors (see protocol for relevant disease sites) patients (=\< 5 metastatic lesions at the time of study entry)
* Candidate for definitive local therapy to all sites of active disease per the discretion of the treating physicians
* No more than 4 prior lines of systemic therapy administered to treat metastatic disease
* Pathologically confirmed diagnosis of cancer as specified in protocol
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Absolute neutrophil count (ANC) \>= 500/mcL (performed within 6 weeks prior to study enrollment)
* Platelets \>= 25,000/mcL (performed within 6 weeks prior to study enrollment)
* Hemoglobin \>=7 g/dL (performed within 6 weeks prior to study enrollment)
* Serum total bilirubin =\< 1.5 mg/dl (except for subjects with Gilbert syndrome, who may have total bilirubin \< 3.0 mg/dl) OR direct bilirubin =\< upper limit normal (ULN) for subjects with total bilirubin levels \> 1.5 mg/dl (performed within 6 weeks prior to study enrollment)
* Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) =\< 3 X ULN OR =\< 5 X ULN for subjects with liver metastases (performed within 6 weeks prior to study enrollment)
Exclusion Criteria:
* Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation t…
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.