Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-01-03 @ 7:57 PM
Study NCT ID:
NCT03735758
Status:
TERMINATED
Last Update Posted:
2021-09-22
First Post:
2018-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life in Patients With Non-adipocyte Soft Tissue Sarcoma Under Palliative Chemotherapy or Pazopanib
Sponsor:
GWT-TUD GmbH
Organization:
Study Overview
Official Title:
Quality of Life in Patients With Non-adipocyte Soft Tissue Sarcoma Under Palliative Chemotherapy or Pazopanib - a Randomized, Controlled Trial
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
problems with recruiting
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PazoQoL
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.
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.
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
• 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: