Neoplasms

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Quality of Life

Soft Tissue Sarcoma

Pazopanib (800mg/each day) or guideline conform chemotherapy

pazopanib or guideline conform chemotherapy

Markus Schuler, Dr.

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.

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

multicentric, controlled, randomized, open Label, parallel-group, prospective

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

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

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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Quality of Life in Patients With Non-adipocyte Soft Tissue Sarcoma Under Palliative Chemotherapy or Pazopanib	NCT03735758	Soft Tissue Sar...	pazopanib or gu...	18 Years -	GWT-TUD GmbH
Quality of Life in Patients With Non-adipocyte Soft Tissue Sarcoma Under Palliative Chemotherapy or Pazopanib	NCT03735758	Soft Tissue Sar...	pazopanib or gu...	18 Years -	GWT-TUD GmbH

Spots Global Cancer Trial Database for pazopanib or guideline conform chemotherapy