A Randomized Study Investigating Preoperative Chemotherapy Followed by Surgery versus Surgery Alone in Patients with High Risk Retroperitoneal Sarcoma, STRASS2 Trial

Active:	Yes
Cancer Type:	Sarcoma	NCT ID:	NCT04031677
Trial Phases:	Phase III	Protocol IDs:	EA7211 (primary) EA7211 NCI-2022-10255
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	ECOG-ACRIN Cancer Research Group
NCI Full Details:	http://clinicaltrials.gov/show/NCT04031677

Summary

This phase III trial compares the effect of adding chemotherapy (doxorubicin or epirubicin hydrochloride [epirubicin] with ifosfamide or dacarbazine) before standard surgery versus surgery alone in improving long-term survival in patients with retroperitoneal sarcomas that are able to be removed by surgery (resectable). Chemotherapy drugs, such as doxorubicin, epirubicin, ifosfamide, and dacarbazine, 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. Giving chemotherapy before surgery may make the tumor smaller and easier to remove and may increase patient survival, compared to surgery alone.

Objectives

PRIMARY OBJECTIVE:
I. To assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk dedifferentiated liposarcoma (DDLPS) and leiomyosarcoma (LMS) patients as measured by disease free survival.

SECONDARY OBJECTIVES:
I. To assess whether there is a difference in the overall survival, recurrence free survival, distant metastases free survival, cumulative incidence of local recurrences and cumulative incidence of distant metastases between patients undergoing curative-intent surgery alone and those undergoing preoperative chemotherapy followed by curative intent surgery.
II. To assess tumor response in patients undergoing preoperative chemotherapy.
III. To assess the toxicity profile of preoperative chemotherapy given as "neoadjuvant" treatment to curative intent surgery in patients with retroperitoneal sarcoma (RPS), and of surgery alone.
IV. To assess whether there is a difference in quality of life between patients undergoing curative intent surgery alone and those undergoing preoperative chemotherapy followed by curative intent surgery.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo surgery on study. Patients also undergo collection of blood samples throughout the study and undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) at screening and follow up.

ARM II: Patients receive doxorubicin (or equivalent epirubicin) IV bolus infusion on day 1 with ifosfamide IV over 4 hours on days 1-3 or dacarbazine IV over 15-30 minutes on days 1-4. Cycles repeat every 21 days for 3 cycles and then patients undergo surgery on study. Patients also undergo collection of blood samples and undergo CT and/or MRI throughout the study.

After completion of study treatment, patients are followed up at 12, 18, 24, 36 and 48 weeks and every 4 months until month 24 after randomization. After 24 months, patients are followed every 6 months until occurrence of recurrence or death.

Treatment Sites in Georgia

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

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