RecruitingPhase 2NCT04776525

Sequential Neoadjuvant Chemotherapy in Soft Tissue Sarcoma

Sequential Neoadjuvant Ifosfamide and Doxorubicin in Localized High-grade Soft Tissue Sarcoma of Extremities and Trunk Wall


Sponsor

Oslo University Hospital

Enrollment

49 participants

Start Date

Apr 27, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Nearly half of patients with high-grade, localized soft tissue sarcoma (STS) of extremities and trunk wall develop disease recurrence after local therapy. Adjuvant chemotherapy with ifosfamide and doxorubicin may improve long-term disease-free survival, but the benefit of adjuvant treatment is limited and predictive factors for treatment response are lacking. The aim of this study is to explore sequential treatment with ifosfamide and doxorubicin in a neoadjuvant setting and to investigate biomarkers predictive of treatment response.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a sequential chemotherapy approach (giving different drug combinations one after the other) before surgery for people with high-grade soft tissue sarcomas (aggressive tumors of the muscles, fat, nerves, or connective tissue). The goal is to shrink the tumor before it's removed. **You may be eligible if...** - You are 18 or older - You have been diagnosed with a specific type of soft tissue sarcoma (including leiomyosarcoma, synovial sarcoma, undifferentiated pleomorphic sarcoma, or several others) - Your tumor is located in a limb, the shoulder/hip girdle, or the chest/abdominal wall - The tumor is at least 5 cm in its longest dimension - The tumor is grade 2 or higher (moderate to high-grade) - Your heart, liver, kidneys, and blood counts are adequate **You may NOT be eligible if...** - Your sarcoma is a low-grade type - Your tumor is in an internal organ (not the limbs or trunk) - Your cancer has already spread to distant organs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIfosfamide

3 g/m2 each day for three days

DRUGDoxorubicin

80 mg/m2 over four hours day 1


Locations(2)

Haukeland University Hospital

Bergen, Norway

Oslo University Hospital

Oslo, Norway

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NCT04776525


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