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

Soft Tissue Sarcoma Adult Clinical Trial

— PazoQoL  

Official title:

Quality of Life in Patients With Non-adipocyte Soft Tissue Sarcoma Under Palliative Chemotherapy or Pazopanib - a Randomized, Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03735758
• Other study ID #: PazoQoL
• Status: Terminated
• Phase: Phase 4
• Start date: November 2, 2018
• Est. completion date: October 6, 2020

Study information

• Verified date: September 2019
• Source: GWT-TUD GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Finding the balance between toxicity and benefit should be the major goal when negotiating about the therapeutic regimen. This becomes nowadays even more important, since there are emerging options in the field of sarcoma therapy. Especially in the palliative treatment of sarcoma patients, knowing that na single drug can provide an overall survival benefit, physicians have to incorporate the patient's preferences and goals in life when consulting them. The study will allow patients with several types of soff tissue sarcoma to be included. After progression under current therapy, the patient will be randomized in a 1:1 fashion and allocated to either pazopanib or investigator's choice. Quality of life (QoL) and other secondary outcome measures will be recorded continuously. The aim of the study is to assess patient reported outcomes (PROs), which should be the primary aim when treating these patients.

Description:

Primary objectives • Assess the overall quality of life (QoL) under treatment with pazopanib or physician-preferred chemotherapy after 9 weeks Secondary objectives - Assess the overall QoL under treatment with pazopanib compared with the physician's preference of chemotherapy three times in Cycle 1 and Cycle 3 - intergroup evaluation of pain - intergroup evaluation of fatigue and its different categories (physical, mental, cognitive, emotional) - intergroup evaluation of anorexia/cachexia - intergroup evaluation of satisfaction with care - Evaluation of the association of QoL with criteria of response - Evaluation of the QoL of all patients during follow up (FU) intergroup evaluation of treatment effects on survival - Evaluation of the prediction of severe early toxicity in elderly patients receiving palliative therapy - Safety and efficacy of the different treatment regimens Exploratory Endpoints: - QLQ-C30 sum score AUC (Area Under the Curve) - Questionnaire Completion Times of QLQ-C30 - Questionnaire Completion of Time Tradeoff

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: October 6, 2020
• Est. primary completion date: October 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma Adult

Intervention

Drug:
• pazopanib or guideline conform chemotherapy
Pazopanib (800mg/each day) or guideline conform chemotherapy

Locations

Country	Name	City	State
Germany	Sarkomzentrum Berlin-Brandenburg	Bad Saarow
Germany	Charite	Berlin
Germany	Vivantes Klinikum Spandau	Berlin
Germany	Universitätsklinikum Dresden	Dresden
Germany	Uniklinik Frankfurt	Frankfurt
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Uniklinikum Heidelberg	Heidelberg
Germany	Universitätsklinikum Mannheim	Mannheim
Germany	Uniklinik Großhadern	München
Germany	Universitätsklinik der Paracelsus Privatuniversität Nürnberg	Nürnberg

Sponsors (1)

Lead Sponsor	Collaborator
GWT-TUD GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sum scores of the overall Quality of live (Qol) recorded with the questionaire "QLQ-C30" in patients with pazopanib versus chemotherapy treatment.	The 30 items of the QLQ-C30 questionaire distribute in diverse subscales (for example: cognitive function, pain and emotional function). The sum score of QLQ-C30 is generated by average of the normative values of all subscales. The higher the sum score the higher the Quality of live (Qol).	9 weeks