Doxorubicin hydrochloride for High-grade soft tissue sarcoma

Inclusion criteria

• {"criterion_text":"- ≥ 18 years of age at the time of informed consent.\n- Adequate organ function and bone marrow reserve as indicated by the following laboratory assessments: a. Hemoglobin ≥ 8.0 g/dL b. Neutrophil count ≥ 1.0 x 109/L c. Platelet count ≥ 75 x 109/L d. Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) e. Creatinine clearance ≥ 60 ml/min based on Cockcroft Gault estimation or direct measurement\n- Negative Hepatitis B and C and HIV serology.\n- Adequate contraception in women of childbearing potential (WOCBP) and their fertile partners. WOCBP should have a negative highly sensitive serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication. A woman is considered fertile following menarche and until becoming post-menopausal unless permanently sterile (see appendix 5 for definitions). WOCBP should be willing to use one of the mentioned highly effective methods of birth control mentioned below or be surgically sterile, or abstain from heterosexual activity for the course of the study through 1 year after the last dose of study medication. Methods considered as highly effective birth control methods include combined (estrogen and progestogen containing) or progestogen-only hormonal contraception associated with inhibition of ovulation (oral, intravaginal, injectable, implantable or transdermal), intrauterine device (including hormone-releasing), male condom, bilateral tubal occlusion, vasectomised partner or sexual abstinence\n- Histological diagnosis of soft tissue sarcoma belonging to one of the following histotypes: a. Leiomyosarcoma b. Malignant peripheral nerve sheath tumor c. Undifferentiated pleomorphic sarcoma d. Myxofibrosarcoma e. Synovial sarcoma f. Pleomorphic liposarcoma g. Pleomorphic rhabdomyosarcoma h. Unclassified spindle cell sarcoma\n- To identify molecular markers of therapy response/resistance and survival outcome, beyond TP53 mutations\n- To assess safety and tolerability of the study treatment\n- To assess quality of life during treatment as measured by EORTC QLQC30\n- Tumor localized in extremity, girdle and/or trunk ...\n- The primary tumor must be available for biopsy collection at protocol inclusion.\n- Patients must have a measurable tumor according to RECIST v1.1.\n- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1."}

Exclusion criteria

• {"criterion_text":"- Any prior therapy for soft tissue sarcoma.\n- Co-morbidity that, based on the assessment of the treating physician, may preclude the study treatment.\n- Pregnant or lactating patients.\n- 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.\n- 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.\n- Urinary obstruction.\n- Known hypersensitivity towards ifosfamide, doxorubicin or pegfilgrastim, their metabolites and other ingredients in the drug administration formulation.\n- 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.\n- Left ventricular ejection fraction (LVEF) < 50%.\n- 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 XML File Identifier: BHwdoUlYtVp7SkuvRHHClDOTTOw= Page 15/24 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.\n- Patients not able to give an informed consent or comply with study regulations as deemed by study investigator."}

Primary endpoints

• {"endpoint_text":"- Overall response rate (ORR), defined as partial or complete response as assessed by RECIST 1.1.","definition_or_measurement_approach":"Defined as partial or complete response as assessed by RECIST v1.1."}

Secondary endpoints

• {"endpoint_text":"- Diseasefree survival and overall survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall response rate defined as partial or complete response","definition_or_measurement_approach":""}
• {"endpoint_text":"- Adverse event, serious adverse event and dose reductions or discontinuation due to toxicity.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change from baseline in EORTC QLQ-C30 scores.","definition_or_measurement_approach":""}

Norway

Earliest CTIS Part Ii Submission Date

08-10-2024

Latest Decision Or Authorization Date

27-02-2025

Processing Time Days

142

Number Of Sites

2

Number Of Participants

50

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway