Quality of Life in Patients With Non-adipocyte Soft Tissue Sarcoma Under

Status Terminated

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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03735758
Study type	Interventional
Source	GWT-TUD GmbH
Contact
Status	Terminated
Phase	Phase 4
Start date	November 2, 2018
Completion date	October 6, 2020

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms