BridgeMD
New treatment option for Soft Tissue Sarcoma
Official title Sequential Neoadjuvant Chemotherapy in Soft Tissue Sarcoma
ClinicalTrials.gov ID: NCT04776525
What this study is testing
What is Ifosfamide?
Ifosfamide is an investigational medicine, being studied as a potential treatment for soft tissue sarcoma.
Also referred to as Holoxan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- Clinical evidence of serious coagulopathy. Prior arterial/venous thrombosis or embolism does not exclude patients from inclusion, unless patient is...
- Urinary obstruction.
- Known hypersensitivity towards ifosfamide, doxorubicin or pegfilgrastim, their metabolites and other ingredients in the drug administration...
- New York Heart Association class II-IV heart disease, myocardial infarction within 6 months of diagnosis of soft tissue sarcoma, active ischemia or...
See the full eligibility criteria
- ≥ 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...
- 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.
- Adequate contraception in women of childbearing potential (WOCBP) and their fertile partners during the study and until 6 months after end of study treatment. WOCBP should have a negative highly sensitive serum or urine...
- 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...
- 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 how well it works assessment of this clinical trial are not eligible. Patients...
- 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...
- Pregnant or lactating patients.
The study team makes the final eligibility decision.
Where it's taking place
- Bergen, Norway
- Oslo, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bergen, Norway; Oslo, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.