Neoadjuvant Lurbinectedin and Preoperative Radiation for Treating Soft Tissue Sarcomas (NCT06217536) | Clinical Trial Compass
WithdrawnPhase 1/2
Neoadjuvant Lurbinectedin and Preoperative Radiation for Treating Soft Tissue Sarcomas
Stopped: Business decision
0Started 2024-10-31
Plain-language summary
This is a multi-center, multi-arm open-label phase Ib/II clinical study assessing the efficacy of concurrent lurbinectedin in combination with radiotherapy in patients with locally advanced, resectable, high-grade sarcomas.
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
. Must have histologically or cytologically confirmed diagnosis of locally advanced soft tissue sarcoma of extremity, trunk or retroperitoneum that is resectable and for which preoperative radiotherapy is considered appropriate.
. Including metastatic (stage IV) disease for which radiotherapy and surgical resection of the primary tumor are indicated.
. Grade 1 myxoid liposarcoma can be included if preoperative radiotherapy is considered appropriate.
. For all other sarcomas, only grade 2 or 3 will be included.
. Those with locally recurrent sarcoma after surgery alone are eligible for enrollment if other inclusion criteria are met.
. Must have measurable disease defined as a tumor size at least \>= 5 cm in the longest diameter as measured by Computerized tomography (CT) scan or Magnetic resonance imaging (MRI) for which radiation is feasible and indicated.
. Age \>=18 years.
. Eastern Cooperative Oncology Group (ECOG) performance status \<= 1 (Karnofsky ≥ 70%).
Exclusion criteria
. Has the following histologic subtypes: gastrointestinal stromal tumor (GIST), desmoid, Ewing sarcoma, bone sarcomas, Kaposi sarcoma.
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
Proportion of participants with dose-limiting toxicities (DLTs) (Phase 1b)
. Prior history of trabectedin or lurbinectedin treatment.
. Prior radiation therapy in excess of 20 Gray (Gy) conventionally fractionated radiotherapy (RT) to the site of the current diagnosis of sarcoma. No overlap with prior radiation fields in excess of 20 Gy is allowed.
. Currently receiving treatment in another invasive investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
. Known central nervous system (CNS) disease, except for treated brain metastasis: Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS); Gamma Knife, linear particle accelerator (LINAC), or equivalent) or a combination as deemed appropriate by the treating physician. Participants with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
. History of allergic reactions attributed to compounds of similar chemical or biologic composition to lurbinectedin.
. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
. Participants on strong or moderate cytochrome P450 (CYP)3A inducers or inhibitors and cannot be substituted for other drugs.