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.
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|