Quality of Life in Patients With Non-adipocyte Soft Tissue Sarcoma Under Palliative Chemotherapy or Pazopanib (PazoQoL)

This is an interventional treatment trial for Soft Tissue Sarcoma Adult focused on measuring in-label prescription, Quality of Life, pazopanib, chemotherapy Read More

Inclusion Criteria:

• The informed consent form must be signed before any study specific tests or procedures are done
• Male or female patients aged 18 years and older at the first screening visit
• Histologically confirmed diagnosis of advanced or metastatic non adipocyte soft tissue sarcoma (STS)
• Suitable for treatment with pazopanib in an in-label prescription
• Patients with a life expectancy of at least 6 months
• Eastern Co-operative Oncology Group (ECOG) performance status 0-2
• Adequate organ function as given in Table 1
• For patients with previous anthracycline therapy a normal heart function needs to be documented with an left ventricular ejection fraction (LVEF) of minimal 50% (echocardiogram)
• Patients must be willing and able to fill in the Quality of live (QoL) questionnaires using a tablet PC
• Ability to understand and follow study-related instructions
• Confirmation of the subject's health insurance coverage prior to the first visit

Exclusion Criteria:

• Pretreatment with pazopanib
• Contraindications according to the local Summary of product characteristics ( SmPC) of Votrient®

• Patients having to following STS specific tumors

  • adipocyte sarcoma including all subtypes,
  • all rhabdomyosarcoma, which are not alveolar or pleomorph
  • Chondrosarcoma
  • Osteosarcoma
  • Ewing-tumors, i.e. primitive neuroectodermal tumors (PNET), gastrointestinal stromal tumor (GIST)
  • Dermatofibrosarcoma protuberans
  • inflammatory myofibroblastic sarcoma
  • Malignant mesothelioma
  • Mixed mesenchymal and epidermal tumors of the uterus Other malignant underlying diseases with the exception of the following:
  • Free of disease for at least 3 years
  • Completely resected, non-melanoma skin cancer
  • Successfully treated carcinoma in situ
  • Patients with metastases of the central nervous system (CNS) at screening, which are asymptomatic AND do not require treatment with steroids or enzyme-inducing anticonvulsant drugs
  • Patients with metastases of the CNS, which are already treated (operation and/or radiotherapy, radiosurgery or gamma-knife)
• Major surgery or trauma within 28 days before the first dose of study medication and / or presence of a non-healing wound, fracture, or ulcer
• Clinical indications of an active bleeding or a bleeding diathesis
• Known endobronchial lesions or lesions that infiltrate the large pulmonary artery
• Hemoptysis of> 2.5 mL within 8 weeks before the first dose of study drug
• Existing uncontrolled infection
• Heart rate-corrected QT-time according to the Fridericia's-formula (QTcF) 450 ms in males and 460 ms in females

• History of one or more of the following cardiovascular diseases within the last 6 months:

  • Cardiac angioplasty or coronary stent
  • Myocardial infarction
  • Unstable angina pectoris
  • Coronary artery bypass surgery
  • Symptomatic peripheral arterial disease
• Cardiac insufficiency New York Heart Association (NYHA) functional dass III or IV
• Poorly controlled hypertension defined as systolic blood pressure 140 mmHg or diastolic blood pressure 90 mmHg
• History of cerebrovascular disease, including transient ischemic attacks (TIA), pulmonary embolism or untreated deep vein thrombosis within 6 months prior to study entry. Patients with deep vein thrombosis who have received therapeutic anticoagulation for a minimum of 6 weeks might be included in the study.
• Clinically significant gastrointestinal changes that increase the risk of gastrointestinal bleeding
• Clinically significant gastrointestinal changes that may affect the absorption of the study drugs

• Treatment with any of the following anti-neoplastic therapies:

  • Irradiation or Tumor embolization within 14 days prior to the first dose of study drug
  • Chemotherapy, immunotherapy, biological therapy, study medication or hormonal therapy within 14 days or 5 half lives of substance (whichever is langer) prior to the first dose of study drug
• If the discontinuation of prohibited medication (see Section 6.9) at least 14 days or 5 half-lives of substance (whichever is langer) prior to the first dose of pazopanib is medically not acceptable or refused by the patient
• A history of hypersensitivity to any of the study drugs or their ingredients or to drugs with similar chemical structure
• Addiction or other diseases that preclude the patient from appropriately assessing the nature and scope as well as possible consequences of the clinical trial
• Pregnant or breast-feeding women

• Women of childbearing potential unless women who meet the following criteria:

  • Post-menopausal (12 months natural amenorrhea without any application of a hormonal contraceptive or hormonal substitution therapy))
  • Postoperatively (6 weeks after bilateral ovariectomy with or without hysterectomy)
  • Regular and correct use of a contraceptive method with error rate <1% per year such as implants, depot injections, oral contraceptives or intrauterine devices during treatment and up 6 months after end of treatment
  • Sexual abstinence
  • Vasectomy of the partner
• Men of sexual activity with women of childbearing potential who are not willing to use an effective barrier method of contraception during and up to 6 months after the end of therapy