Phase II Study of Regorafenib as Maintenance Therapy (NCT03793361) | Clinical Trial Compass
CompletedPhase 2
Phase II Study of Regorafenib as Maintenance Therapy
France127 participantsStarted 2019-05-15
Plain-language summary
Multicenter double-blind placebo-controlled randomized Phase II study comparing regorafenib® to placebo, as maintenance therapy in metastatic soft-tissue non-adipocytic sarcomas experiencing stable disease or response after 6 cycles of doxorubicin-based chemotherapy as 1st line chemotherapy.
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:
* Age ≥18 years
* Histologically proven soft tissue sarcoma including leiomyosarcoma, synovial sarcoma and other sarcomas
* Patients in partial response or stable disease after 6 cycles of doxorubicin-based first-line chemotherapy for metastatic/locally advanced soft tissue sarcoma
* Metastatic/locally advanced disease not amenable to surgical resection with curative intent
* Eastern Cooperative Oncology Group (ECOG) Performance Status =0 or 1
* Measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by RECIST 1.1.
* Available tumor tissue for translational research program
* Adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation:
* Absolute neutrophil count (ANC) ≥1,500/mm3
* Platelets ≥100,000/mm3
* Hemoglobin ≥9.0 g/dL
* Serum creatinine ≤1.5 x upper limit of normal (ULN)
* Glomerular filtration rate (GFR) ≥30 ml/min/1.73m2
* AST and ALT ≤2.5 x ULN ( ≤5.0 × ULN for patients with liver involvement of their cancer)
* Bilirubin ≤1.5 X ULN
* Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN with liver involvement of their cancer)
* Lipase ≤1.5 x ULN
* Spot urine must not show 1+ or more protein in urine or the patient will require a repeat urine analysis. If repeat urinanalysis shows 1+ protein or more, a 24-hour urine collection will be required and must show total protein excretion \<1000 mg/24 hours
* INR/PTT ≤1.5 x ULN (Patients who are therapeuti…
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
To assess the efficacy of regorafenib compared to placebo
Timeframe: from the date of randomization to the date of first observed disease progression (according to RECIST 1.1 criteria) or death from any cause, up to 12 months after the beginning of the treatment