Actively Recruiting
Sequential Neoadjuvant Chemotherapy in Soft Tissue Sarcoma
Led by Oslo University Hospital · Updated on 2025-08-14
49
Participants Needed
2
Research Sites
800 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
H
Haukeland University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sequential Neoadjuvant Chemotherapy in Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of informed consent
- Histological diagnosis of soft tissue sarcoma of specified types including leiomyosarcoma, malignant peripheral nerve sheath tumor, undifferentiated pleomorphic sarcoma, myxofibrosarcoma, synovial sarcoma, pleomorphic liposarcoma, pleomorphic rhabdomyosarcoma, or unclassified spindle cell sarcoma
- Malignancy grade 2 or higher according to the FNCLCC grading system
- Tumor localized in extremity, girdle, and/or trunk wall
- Primary tumor size 5.0 cm or larger measured by MRI or CT scan
- Tumor located below or involving the superficial fascia (deep-seated) according to WHO classification
- Tumor must be available for biopsy collection at study inclusion
- Measurable tumor by RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Written informed consent given before registration
- Adequate organ function and bone marrow reserve with hemoglobin ≥ 8.0 g/dL, neutrophils ≥ 1.0 x 10^9/L, platelets ≥ 75 x 10^9/L, total bilirubin ≤ 1.5 times upper limit of normal, and creatinine clearance ≥ 60 ml/min
- Negative tests for Hepatitis B, Hepatitis C, and HIV
- Adequate contraception for women of childbearing potential and their fertile partners during study and up to 6 months after treatment, including a negative pregnancy test prior to first dose
You will not qualify if you...
- Any prior therapy for soft tissue sarcoma
- Presence of locoregional or distant metastasis at diagnosis (lung nodules <10 mm of uncertain cause allowed)
- Serious coagulopathy or unfitness due to thrombosis or embolism as judged by the oncologist
- Urinary obstruction
- Known allergy to ifosfamide, doxorubicin, pegfilgrastim, or their components
- Heart disease classified as New York Heart Association class II-IV, recent myocardial infarction within 6 months, active ischemia, uncontrolled cardiac conditions, or reduced left ventricular ejection fraction below 50%
- Concurrent or prior malignant diseases likely to interfere with the trial safety or efficacy assessment, except certain breast or prostate cancers under specific treatments
- Inability to give informed consent or comply with study requirements
- Significant other health conditions that might impact safety or protocol compliance, such as active infections or uncontrolled pulmonary or liver disease
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Haukeland University Hospital
Bergen, Norway
Actively Recruiting
2
Oslo University Hospital
Oslo, Norway
Actively Recruiting
Research Team
K
Kjetil Boye, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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