Soft Tissue sarkomas (STS) are rare tumors, orginated from connectivetissue and supporting connective tissue. For patients with progressedSTS are different options for palliative treatment. In PazoQol the twooptions Chemotherapy and Pazopanib should be compared with focus onpatient reported outcomes.

Phase 1

• Conditions: Soft tissue sarcoma (STS); MedDRA version: 15.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: HLTClassification code 10041298Term: Soft tissue sarcomas histology unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10075333Term: Soft tissue sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-003382-10-DE
• Lead Sponsor: GWT-TUD GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-06
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

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 nonadipocyte
STS
• Suitable for treatment with pazopanib in an in-label prescription
• Patients with a life expectancy of at least 6 months
• 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 LVEF of minimal 50%
(echocardiogram or MUGA scan)
• Patients must be willing and able to fill in the 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

Subjects are to be excluded from the study if they display any of the
following criteria:
• Pretreatment with pazopanib
• Contraindications according to the local SmPC of Votrient® (see
Appendix 1)

Patients having to following STS specific Tumors:
oadipocyte sarcoma including all subtypes
oall rhabdomyo sarcoma,
oChondro sarcoma
oOsteo sarcoma
oEwing-tumors,
oDermatofibrosarcoma protuberans
oInflammatory myofibroblastic sarcoma
oMalignant mesotheliom
oMixed mesenchymal and epidermal tumors of the uterus.

• Other malignant underlying diseases with the exception of the
following:
o Free of disease for at least three years
o Completely resected, non-melanoma skin cancer
o Successfully treated carcinoma in situ
o 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
o 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 (procedures like insertion of an ureteral stent are not regarded
as major surgery)
• 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 eight 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:
o Cardiac angioplasty or coronary stent
o Myocardial infarction
o Unstable angina pectoris
o Coronary artery bypass surgery
o Symptomatic peripheral arterial disease
• Cardiac insufficiency NYHA functional class III or IV
Poorly controlled hypertension defined as systolic blood pressure =
140 mmHg or diastolic blood pressure = 90 mmHg. (Note: Start or
adjustment of antihypertensive medication prior to study entry is
allowed. Blood pressure should in this case be be stable for at least 2 weeks and re-evaluated at least
twice with a minimum distance of 1 hour. The average of all
measurements must be <140/90 to allow inclusion of the patient).
• 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 six weeks might be included in the study.
• Clinically significant gastrointestinal changes that increase the risk
of gastrointestinal bleeding, including (but not exclusively):
o Active peptic ulceration
o Known intraluminal metastases with a risk of bleeding
o Inflammatory bowel disease (e.g. Morbus Crohn, Colitis ulcerosa) or
other gastrointestinal disease with increased risk of perforation
o A history of existing abdominal fistula, gastrointestinal perforation
or intra-abdominal abscess within 28 days prior to study entry
• Clinically significant gastrointestinal changes that may affect the
absorption of the study drugs, including (but not exclusively):
malabsorption or resection of the stomach or small intestine
• Treatment with any of the following

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • Compare the overall quality of life (QoL) under treatment with<br>pazopanib or physician-preferred chemotherapy after 9 weeks;Secondary Objective: Patient-reported outcomes (PROs)<br>Clinical outcomes<br>Predictors of toxicity in patients 60 years and older<br>Safety parameters;Primary end point(s): The primary variable assessed in this study is the overall QoL<br>measured by EORTC QLQ-C30 (sum score) after 9 weeks of treatment.;Timepoint(s) of evaluation of this end point: after 9 weeks of treatment.