Eribulin Mesylate and Radiation Therapy in Treating Patients With Retroperitoneal Liposarcoma That Can Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT03361436|
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Liposarcoma Retroperitoneal Neoplasm||Drug: Eribulin Mesylate Radiation: Intensity-Modulated Radiation Therapy Other: Laboratory Biomarker Analysis Procedure: Quality-of-Life Assessment Other: Questionnaire Administration Procedure: Therapeutic Conventional Surgery||Phase 1|
I. 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.
I. 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 course 1. Treatment repeats every 21 days for up to 3 courses 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1B Trial of Preoperative Eribulin and Radiation for Retroperitoneal Liposarcoma|
|Actual Study Start Date :||March 19, 2018|
|Estimated Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||February 28, 2022|
Experimental: Treatment (eribulin mesylate, IMRT, surgery)
Patients 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 course 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo surgery within 3-10 weeks after radiation therapy.
Drug: Eribulin Mesylate
Radiation: Intensity-Modulated Radiation Therapy
Other: Laboratory Biomarker Analysis
Procedure: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Procedure: Therapeutic Conventional Surgery
- Incidence of dose limiting toxicities according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 [ Time Frame: Up to 42 days ]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.
- Change in subject-reported quality of life assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Baseline up to 9 weeks after surgery ]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).
- 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) [ Time Frame: Up to 10 years ]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.
- Overall survival rate [ Time Frame: Up to 10 years ]Median overall survival with 95% CI and survival rates at 2, 5 and 10 years will be estimated using Kaplan-Meier method.
- Pathologic response defined as the percentage of tumor with treatment change, including necrosis, fat maturation and hyalinization [ Time Frame: Up to 10 years ]Descriptive statistics including mean, median, standard deviation, and 95% confidence interval of pathologic response will be reported for the study.
- Rate of early surgical resection [ Time Frame: 3 weeks after radiation therapy ]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.
- Rate of enrollment [ Time Frame: Up to 18 months ]
- Rate of R0 resection defined as the proportion of surgical specimens with microscopically negative margins [ Time Frame: Up to 10 years ]The rate of R0 resection, along with exact two-sided 95% confidence intervals, will be reported for the study.
- Rate of serious post-operative complications [ Time Frame: Up to 9 weeks following surgery ]This rate, along with exact two-sided 95% confidence intervals, will be reported for the study.
- Rate of surgical resection [ Time Frame: Beyond 10 weeks of radiation ]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.
- Recurrence-free survival rate [ Time Frame: Up to 10 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361436
|United States, Oregon|
|OHSU Knight Cancer Institute||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Lara E. Davis 503-494-8423 email@example.com|
|Principal Investigator: Lara E. Davis|
|Principal Investigator:||Lara Davis||OHSU Knight Cancer Institute|