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LiposarcomaPhase 1NCT03361436

Eribulin and Radiation Therapy in Treating Patients With Retroperitoneal Liposarcoma That Can Be Removed by Surgery

A Phase 1 study testing Eribulin Mesylate, Intensity-Modulated Radiation Therapy and Laboratory Biomarker Analysis in people with Liposarcoma and Malignant Abdominal Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase Ib trials studies the side effects and best dose of eribulin mesylate when given together with radiation therapy in treating patients with retroperitoneal liposarcoma that can be removed by surgery. Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
Eribulin Mesylate, Intensity-Modulated Radiation Therapy and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
19 Mar 2018to 14 Apr 2033
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Pathologically confirmed diagnosis of liposarcoma; all subtypes are eligible
  • Sufficient archival tissue available for correlative studies; submission of formalin-fixed paraffin-embedded (FFPE) tumor tissue from a previous biopsy or resection is required, and the most recent specimen is preferred; if a FFPE block cannot be provided, then 10 unstained, positively-charged slides of 4-5 um thickness must be submitted; if insufficient archival tissue is available, a repeat biopsy will be necessary
  • Primary or recurrent retroperitoneal, scrotal/spermatic cord or abdominal tumor
  • For subjects between the ages of 12-18 years only, body surface area (BSA) must be >= 1.5 m^2
  • All sites of disease must be resectable or borderline resectable as assessed by a surgical oncologist with experience in retroperitoneal sarcoma resection after discussion in our institutional multidisciplinary sarcoma tumor board conference
  • All sites of disease must be targetable with intensity-modulated radiation therapy (IMRT) with acceptable morbidity and without exceeding normal tissue dose constraints as assessed by a radiation oncologist
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  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening
  • Fridericia's correction formula (QTcF) interval on standard 12-lead electrocardiography (ECG) parameters at screening (defined as the mean of the triplicate ECGs) of < 450 msec for males and < 470 msec for females
  • Ejection fraction of >= 50%
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
  • Individuals of childbearing potential must be willing to use adequate contraception throughout the study and for 3 weeks after study drug discontinuation
  • Absolute neutrophil count (ANC) >= 1 K/cu mm
  • Platelets (no transfusion within prior 7 days) >= 100 K/cu mm
  • Hemoglobin (no transfusion within prior 7 days) >= 9.0 g/dL
  • Total bilirubin < institutional upper limit of normal (ULN), except for subjects with documented Gilbert's syndrome, for which =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN
  • Estimated creatinine clearance > 50 mL/min by Cockcroft-Gault equation
  • Ability to understand and the willingness to sign a written informed consent document; subject has signed the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements

Who cannot join

  • Presence of distant metastases; intra-abdominal (regional) spread is allowable if meets inclusion criterial indeterminate or small volume pulmonary nodules may be eligible, if the treating physicians recommend curative-intent resection of the primary tumor despite the presence of possible lung metastases
  • Prior radiation or systemic therapy for the diagnosis of liposarcoma
  • Prior eribulin
  • Grade >= 2 peripheral neuropathy
  • Contraindication to magnetic resonance imaging (MRI), including presence of a pacemaker or aneurysm clip, severe claustrophobia, a known reaction to gadolinium contrast, or body weight exceeding 300 pounds (lbs)
  • Concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of malignancies that have completed therapy and are considered by their physician to be at less than 30% risk of relapse; prior systemic therapy is allowed with the exception of prior eribulin; prior radiation therapy is allowed with the exception of any abdominal, pelvic or retroperitoneal radiation > 10 Gy
Show all 12Show fewer
  • History of uncontrolled arrhythmia, congenital long QT syndrome or torsades de pointes (TdP)
  • Use of more than one medication with a known risk of TdP
  • Major operation within 14 days prior to starting study drug or not recovered from surgical complications; neither tumor biopsy nor central line insertion are considered a major operation
  • Active infection; any systemic antimicrobial therapy must be completed >= 5 days prior to initiation of protocol therapy
  • Pregnant or nursing (lactating) individuals; NOTE: Pregnant individuals are excluded from this study because eribulin is an investigational agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the individual with eribulin breastfeeding should be discontinued; these potential risks may also apply to doxorubicin
  • Unable or unwilling to stop the use of herbal supplements; the use of marijuana or its derivatives is allowed; the use of supplements may be allowed after review by a study pharmacist to confirm no significant risk of interaction with eribulin or radiation

Trial locations and contacts

1 site in 1 country.

United States1 site
  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: A Phase 1B Trial of Preoperative Eribulin and Radiation for Retroperitoneal Liposarcoma

This phase Ib trials studies the side effects and best dose of eribulin mesylate when given together with radiation therapy in treating patients with retroperitoneal liposarcoma that can be removed by surgery. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the recommended phase 2 dose (RP2D) of radiation and eribulin mesylate (eribulin) when used in combination for the preoperative treatment of retroperitoneal liposarcoma.

SECONDARY OBJECTIVES:

  1. To assess the feasibility of a preoperative chemoradiation protocol for retroperitoneal liposarcoma.

II. To assess the surgical outcomes of retroperitoneal liposarcoma resections after preoperative chemoradiation.

III. To assess preliminary anti-tumor activity of eribulin in combination with radiation in subjects with retroperitoneal liposarcoma.

OUTLINE: This is a dose-escalation study of eribulin mesylate.

Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on days 1 and 8 and undergo intensity-modulated radiation therapy once daily (QD) 5 days a week beginning on day 8 of cycle 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo surgery within 3-10 weeks after radiation therapy.

After completion of study treatment, patients will be followed up at 2 weeks, 9 weeks, and then every 6 months for 10 years.

Being tested
Eribulin Mesylate, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Liposarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eribulin MesylateDrug

    Also called B1939 Mesylate, E7389, ER-086526, Halaven

    Given IV

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

    Undergo IMRT

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Therapeutic Conventional SurgeryProcedure or surgery

    Undergo surgery

Study groups in NCT03361436
Study groupRoleWhat they receive
Treatment (eribulin mesylate, IMRT, surgery)ExperimentalPatients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8 and undergo intensity-modulated radiation therapy QD 5 days a week beginning on day 8 of cycle 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo surgery within 3-10 weeks after radiation therapy.
Receives: Drug: Eribulin Mesylate; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Therapeutic Conventional Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting toxicities according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03

    All adverse events will be tabulated and summarized by major organ category, grade, anticipation, and drug attribution. Serious adverse events (SAE) specific incidence and exact 95% confidence interval will be provided where appropriate.

    Measured: Up to 42 days

Secondary outcomes (10)
  1. Rate of enrollment

    Measured: Up to 18 months

  2. Rate of early surgical resection

    The proportion of subjects, along with exact two-sided 95% confidence intervals, undergoing surgical resection before the completion of all planned chemotherapy and radiation will be reported for the study.

    Measured: 3 weeks after radiation therapy

  3. Rate of surgical resection

    The proportion of subjects, along with exact two-sided 95% confidence intervals, undergoing surgical resection later than planned for any reason will be reported for the study.

    Measured: After 10 weeks of radiation, until study completion (up to 4 years)

  4. Change in subject-reported quality of life assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)

    Will apply a mixed effects model to analyze changes in PROMIS symptom measurements at four time points: baseline, C2D8, prior to surgery and 9 weeks postoperative (post-op).

    Measured: Baseline up to 9 weeks after surgery

  5. Rate of R0 resection defined as the proportion of surgical specimens with microscopically negative margins

    The rate of R0 resection, along with exact two-sided 95% confidence intervals, will be reported for the study.

    Measured: Up to 10 years

  6. Rate of serious post-operative complications

    This rate, along with exact two-sided 95% confidence intervals, will be reported for the study.

    Measured: Up to 9 weeks following surgery

  7. Pathologic response defined as the percentage of tumor with treatment change, including necrosis, fat maturation and hyalinization

    Descriptive statistics including mean, median, standard deviation, and 95% confidence interval of pathologic response will be reported for the study.

    Measured: Up to 10 years

  8. Objective response rate (ORR) defined as the proportion of subjects who achieved a complete response (disappearance of all target tumors) or a partial response (>= 30% decrease in the sum of the longest diameters of target tumors)

    Based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The ORR, along with exact two-sided 95% confidence intervals, will be reported for the study.

    Measured: Up to 10 years

  9. Recurrence-free survival rate

    Median recurrence-free survival with 95% confidence interval (CI) and survival rates at 2, 5 and 10 years will be estimated using the Kaplan-Meier method for both local and distant recurrence.

    Measured: Up to 10 years

  10. Overall survival rate

    Median overall survival with 95% CI and survival rates at 2, 5 and 10 years will be estimated using Kaplan-Meier method.

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2017
  2. Study start19 Mar 2018
  3. Primary completion14 Feb 2023
  4. Study completion14 Apr 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03361436
Sponsor's protocol ID
STUDY00017190
Other IDs
NCI-2017-02120, STUDY00017190
Status last verified
Apr 2026
First submitted
28 Nov 2017
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Davis LE, Zhu L, Mayo SC, Latour E, Park B, Huang W, Moloney B, Davis JL, Wakeman K, Sheppard B, Billingsley KG, Vetto J, Valenzuela CD, Eil RL, Rocha F, Hung A, Ryan CW. Concurrent preoperative eribulin and radiation for resectable retroperitoneal liposarcoma: a phase 1B study. Cancer Treat Res Commun. 2026;48:101334. doi: 10.1016/j.ctarc.2026.101334. Epub 2026 Jul 25.

    PubMed 42501677
  • Vatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22.

    PubMed 32827353

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Eribulin Mesylate, Intensity-Modulated Radiation Therapy and Laboratory Biomarker Analysis in people with Liposarcoma and Malignant Abdominal Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicities according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 (time frame: Up to 42 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03361436, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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