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

NCT03735758 | Terminated Phase 4

• 1 other identifier: PazoQoL
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Soft Tissue Sarcoma Adult

Keywords

in-label prescription; Quality of Life; pazopanib; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pazopanib

EXPERIMENTAL

Pazopanib; 800 mg; daily; oral

Drug: pazopanib or guideline conform chemotherapy

Chemotherapy

ACTIVE COMPARATOR

Guideline-conform chemotherapy

Drug: pazopanib or guideline conform chemotherapy

Interventions

pazopanib or guideline conform chemotherapy DRUG

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

Chemotherapy; Pazopanib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GWT-TUD GmbH: lead

Study Sites (10)

Sarkomzentrum Berlin-Brandenburg

Bad Saarow, 15526, Germany

Location

Charite

Berlin, 13353, Germany

Location

Vivantes Klinikum Spandau

Berlin, 13585, Germany

Location

Universitätsklinikum Dresden

Dresden, 01307, Germany

Location

Uniklinik Frankfurt

Frankfurt, 60590, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Uniklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum Mannheim

Mannheim, 68167, Germany

Location

Uniklinik Großhadern

München, 81377, Germany

Location

Universitätsklinik der Paracelsus Privatuniversität Nürnberg

Nuremberg, 90419, Germany

Location

MeSH Terms

Interventions

pazopanib

Study Officials

• Markus Schuler, Dr.

  Helios Klinikum Emil von Behring

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multicentric, controlled, randomized, open Label, parallel-group, prospective

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 8, 2018
• Study Start: November 2, 2018
• Primary Completion: October 6, 2020
• Study Completion: October 6, 2020
• Last Updated: September 22, 2021

Record last verified: 2019-09

Locations

DE (10)