NRSTS2021: Treatment for Non-Rhabdomyosarcoma Soft Tissue Sarcoma
This study is for children and young adults (ages 1-30) with non-rhabdomyosarcoma soft tissue sarcoma (NRSTS), a type of cancer. It's testing different treatments based on your risk level. All participants will have surgery to remove the tumor. Some will also receive proton beam radiation therapy, but at a higher dose than usual. Other treatments being studied include the drugs pazopanib (taken by mouth), ifosfamide (given intravenously, or into a vein), and doxorubicin (also given intravenously). Researchers want to see how long patients live without their cancer returning (event-free survival) and find the safest and most effective doses of the drugs. The study aims to enroll 139 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 139 participants.
- What's involved
- Participants will undergo surgical resection. Depending on their risk group, they may receive proton beam radiation therapy, pazopanib for 7 days, ifosfamide for 3 days, and doxorubicin for 2 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 9 years, with event-free survival measured at 9 years and drug dosage safety measured at 4 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06239272
NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
Recruiting
PHASE1Up to 30InterventionalTreatmentSt. Jude Children's Research HospitalInvestigator-initiated
~139 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Surgical resectionProton beam radiation therapyPazopanibIfosfamideDoxorubicinSelinexor
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event-free survival (EFS)
Measured over 9 years (6 years of accrual and 3 year follow-up after enrollment of last patient
+1 more outcome measured
Conditions
Where it's being run
7 sites across 7 statesGeorgia1
Illinois1
Louisiana1
Massachusetts1
Missouri1
Ohio1
Tennessee1
Study leadership
- Jessica Gartrell, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients must be 1-30 years at the time of the biopsy that established the diagnosis of NRSTS.
Surgical Resection: Patients who had an upfront resection prior to enrollment will be eligible if they are able to begin therapy within 28 days of resection assuming other eligibility criteria are met. Delayed resection is preferred for all patients with intermediate and high-risk disease.
Lansky performance status score ≥ 60 for patients ≤ 16 years of age. Karnofsky performance status score ≥ 60 for patients \>16 years of age. Note patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
Low-grade tumor of any size where R0 or R1 surgical margins are anticipated or achieved.
High-grade tumors that are \< 5 cm where R0 or R1 resection margins are anticipated or achieved.
Creatinine clearance or radioisotope GFR \> 70 mL/min/1.73 m2, or
A normal serum creatinine based on age/gender as follows
Total bilirubin \< 1.5 x upper limit of normal (ULN) for age
SGOT (AST) or SGPT (ALT) \< 2.5 x ULN for age
Ejection fraction of \> 55% by echocardiogram or cardiac MRI
QTc \< 480 msec
No evidence of dyspnea at rest, no exercise intolerance, and a resting pulse oximetry reading \> 94% on room air if there is clinical indication for determination.
Low-grade non-metastatic initially unresectable disease at study enrollment where delayed resection is planned.
High-grade \< 5 cm non-metastatic initially unresectable disease at study enrollment where delayed resection is planned. Of note, patients enrolled on the low-risk arm who were unable to achieve gross total resection where delayed re-resection is planned are eligible for this arm.
High-grade tumor \> 5 cm that is potentially resectable.
Metastatic disease at presentation
Unresectable disease at study enrollment where delayed resection is not anticipated. Of note, patients enrolled on the low-risk arm who were unable to achieve gross total resection where delayed re-resection is not-planned are eligible for this arm.
CIC-DUX4 rearranged sarcoma
Absolute neutrophil count \> 1000/µL
Platelet count \> 100,000/µL
Hemoglobin \> 8 g/dL for patients \< 16 years of age
Hemoglobin \> 9 g/dL for patients \> 16 years of age
Creatinine clearance or radioisotope GFR \> 70 mL/min/1.73 m2, or
A normal serum creatinine based on age/gender as follows
Total bilirubin \< 1.5 x upper limit of normal (ULN) for age
SGOT (AST) or SGPT (ALT) \< 2.5 x ULN for age
Ejection fraction of \> 55% by echocardiogram or cardiac MRI
QTc \< 480 msec
No evidence of dyspnea at rest, no exercise intolerance, and a resting pulse oximetry reading \> 94% on room air if there is clinical indication for determination.
Exclusion
Patients with known primary CNS sarcoma or CNS metastases are not eligible. Note: Brain imaging is not an eligibility requirement. Tumors with intracranial extension will be allowed.
Patients with the following histologic diagnosis are not eligible: intermediate locally aggressive tumors as defined by WHO, malignant rhabdoid tumor, alveolar soft part sarcoma, infantile fibrosarcoma, unresectable/metastatic dermatofibrosarcoma protuberans, inflammatory myofibroblastic tumor, desmoid fibromatosis, rhabdomyosarcoma, desmoplastic small round cell tumor, BCOR-CCNB3 fusion positive sarcoma.
Bleeding diathesis: Patients with evidence of active bleeding or bleeding diathesis will be excluded (Note: Patients aged \> 17 years with excess of 2.5 mL of hemoptysis are not eligible).
Uncontrolled hypertension: Patients with uncontrolled hypertension (CTCAE v5 Grade ≥ 2) are ineligible. Hypertension must be well controlled on stable doses of medication for at least two weeks.
Patients must have had no prior systemic therapy for the treatment of the NRSTS
Patients must have had no prior anthracycline or ifosfamide chemotherapy
Patients must have had no prior use of pazopanib or similar multi-targeted TKI.
CYP3A4 Substrates WITH Narrow Therapeutic Indices: Patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices within 7 days prior to study enrollment, including but not limited to pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible. Note: the use of fentanyl is permitted.
CYP3A4 Inhibitors: Patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to itraconazole, clarithromycin, erythromycin, many NNRTIs, diltiazem, verapamil, and grapefruit juice are not eligible.
CYP3A4 Inducers: Patients chronically receiving drugs that are known potent CYP3A4 inducers within 14 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifampin, and St. John's wort are not eligible (with the exception of glucocorticoids).
Certain medications that are associated with a risk for QTc prolongation and/or Torsade's de Pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible.
Subjects with any condition that may impair the ability to absorb oral medications/investigational product including:
prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel
active peptic ulcer disease
malabsorption syndrome
active peptic ulcer disease
known intraluminal metastatic lesions
inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions which increase the risk of perforation
history of abdominal fistula, gastrointestinal perforation or intra- abdominal abscess within 28 days prior to beginning study treatment.
An untreated pulmonary embolism or DVT in last 6 months or
treated pulmonary embolism or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks
arterial thrombosis in last 12 months
Pregnancy and Breast Feeding Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal/human studies.
Lactating females are not eligible unless they have agreed not to breastfeed their infants during treatment and for a period of 1 month following completion of treatment.
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.
Unwillingness to use an effective contraceptive method for the duration of their study participation and for at least 1 month after treatment is completed if sexually active with reproductive potential.
What this trial measures
- Event-free survival (EFS)9 years (6 years of accrual and 3 year follow-up after enrollment of last patient
We will estimate the 3-year event-free survival for intermediate-risk patients, which is the estimated probability of a patient not having any events within the 3-year follow-up. The events are defined as including local failure, regional failure, distant failure, a subsequent malignant neoplasm, or death, whichever occurred first.
- Maximum tolerated dose (MTD) and/or the recommended phase 2 dosage (RP2D)4 years]
MTD is defined in the study as the highest treatment dose that would deliver desirable treatment effects without resulting in a target toxicity rate greater than 0.3. We will employ the Bayesian optimal interval (BOIN) design to find the MTD in high-risk participants.