AzTrials
AzTrials

Soft Tissue Sarcoma AdultPhase 4PazoQoLNCT03735758

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

A Phase 4 study testing pazopanib or guideline conform chemotherapy in people with Soft Tissue Sarcoma Adult, run by GWT-TUD GmbH at 10 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma Adult
What is being tested?
pazopanib or guideline conform chemotherapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
10 sitesGermany
Study dates
2 Nov 2018to 6 Oct 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 48Show fewer
  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • Sarkomzentrum Berlin-Brandenburg

    Bad Saarow, 15526

  • Charite

    Berlin, 13353

  • Vivantes Klinikum Spandau

    Berlin, 13585

  • Universitätsklinikum Dresden

    Dresden, 01307

  • Uniklinik Frankfurt

    Frankfurt, 60590

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Uniklinikum Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum Mannheim

    Mannheim, 68167

  • Uniklinik Großhadern

    München, 81377

  • Universitätsklinik der Paracelsus Privatuniversität Nürnberg

    Nuremberg, 90419

Other trials in Germany

About this study

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

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.

Read the detailed 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
Being tested
pazopanib or guideline conform chemotherapy
Keywords
in-label prescription, Quality of Life, pazopanib, chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pazopanib or guideline conform chemotherapyDrug

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

Study groups in NCT03735758
Study groupRoleWhat they receive
PazopanibExperimentalPazopanib; 800 mg; daily; oral
Receives: Drug: pazopanib or guideline conform chemotherapy
ChemotherapyActive comparatorGuideline-conform chemotherapy
Receives: Drug: pazopanib or guideline conform chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2018
  2. Study start2 Nov 2018
  3. Primary completion6 Oct 2020
  4. Study completion6 Oct 2020

Why it stopped: problems with recruiting

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
multicentric, controlled, randomized, open Label, parallel-group, prospective
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03735758
Sponsor's protocol ID
PazoQoL
Acronym
PazoQoL
Status last verified
Sep 2019
First submitted
7 Nov 2018
Last updated
22 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing pazopanib or guideline conform chemotherapy in people with Soft Tissue Sarcoma Adult, run by GWT-TUD GmbH at 10 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: problems with recruiting). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The sum scores of the overall Quality of live (Qol) recorded with the questionaire "QLQ-C30" in patients with pazopanib versus chemotherapy treatment. (time frame: 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03735758.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in