Sequential Neoadjuvant Chemotherapy in Soft Tissue Sarcoma

Recruiting now · Phase 2

Conditions studied: Soft Tissue Sarcoma

In brief

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.

Key facts

Study ID

NCT04776525

Run by

Oslo University Hospital

People needed

49

Starts

2021-04-27

Expected to finish

2036-09-01

Last updated by the study team

2025-08-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age at the time of informed consent.
• Histological diagnosis of soft tissue sarcoma belonging to one of the following histotypes:
• Leiomyosarcoma
• Malignant peripheral nerve sheath tumor
• Undifferentiated pleomorphic sarcoma
• Myxofibrosarcoma
• Synovial sarcoma
• Pleomorphic liposarcoma
• Pleomorphic rhabdomyosarcoma
• Unclassified spindle cell sarcoma
• Malignancy grade ≥ 2 according to the Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC) grading system.
• Tumor localized in extremity, girdle and/or trunk wall.
• Primary tumor size ≥5.0 cm as measured in the longest diameter on diagnostic MRI or CT scan.
• Primary tumor location below the superficial fascia or involving the superficial fascia, i.e. deep-seated according to the World Health Organization (WHO) Classification of Tumors of Soft Tissue and Bone (4th edition, 2013).
• The primary tumor must be available for biopsy collection at protocol inclusion.
• Patients must have a measurable tumor according to RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Before patient registration, written informed consent must be given according to national and local regulations.
• Adequate organ function and bone marrow reserve as indicated by the following laboratory assessments:
• Hemoglobin ≥ 8.0 g/dL
• Neutrophil count ≥ 1.0 x 109/L
• Platelet count ≥ 75 x 109/L
• Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)
• Creatinine clearance ≥ 60 ml/min based on Cockcroft Gault estimation or direct measurement
• Negative Hepatitis B and C and HIV serology.

You may not qualify if…

• Any prior therapy for soft tissue sarcoma.
• Locoregional or distant metastasis as assessed by CT and/or MRI at time of diagnosis. Patients with lung nodules <10 mm of uncertain etiology may be included.
• Clinical evidence of serious coagulopathy. Prior arterial/venous thrombosis or embolism does not exclude patients from inclusion, unless patient is considered unfit by study oncologist.
• Urinary obstruction.
• Known hypersensitivity towards ifosfamide, doxorubicin or pegfilgrastim, their metabolites and other ingredients in the drug administration formulation.
• New York Heart Association class II-IV heart disease, myocardial infarction within 6 months of diagnosis of soft tissue sarcoma, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
• Left ventricular ejection fraction (LVEF) < 50%.
• Patients with a prior or concurrent malignant disease whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible. Patients with a history of breast cancer, requiring continued hormonal treatment (e.g. anti-estrogen or an aromatase inhibitor) may be included. Patients with a history of prostate cancer, requiring continued support with luteinizing hormone releasing hormone (LHRH) agonists, with or without androgens, may be included.
• Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.
• Any other significant comorbidities, such as active infection, uncontrolled pulmonary or liver disease, active cystitis, or any other condition, that based on the assessment of the treating physician could compromise compliance with the protocol or predispose the patient to safety risks.
• Pregnant or lactating patients.

Where it is running

• Haukeland University Hospital — Bergen, Norway (enrolling)
• Oslo University Hospital — Oslo, Norway (enrolling)

Full record on ClinicalTrials.gov

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