Last updated: 02/04/2020 14:30:17

Systematic Literature Review and Meta-Analysis of Side Effects of Treatments Used in Advanced Soft Tissue Sarcoma

GSK study ID
201358
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Systematic Literature Review and Meta-Analysis of Side Effects of Treatments Used in Advanced Soft Tissue Sarcoma
Trial description: There is no single data source that specifically addresses the adverse events associated with chemotherapy agents in the treatment of soft tissue sarcoma (STS). To address this gap, we will conduct a systematic literature review of the tolerability and associated toxicities of chemotherapy agents commonly used in the treatment of advanced and metastatic STS. If feasible, we will conduct a meta-analysis to compare information on reported adverse events (AEs) associated with pazopanib and other therapies in the management and treatment of STS.
The aim of this study is to conduct a systematic literature review and meta-analysis to quantitatively and qualitatively answer the following question: How does the occurrence of specific adverse events reported in randomized controlled trials compare between pazopanib versus other recommended systemic therapies in adult patients diagnosed with advanced/metastatic STS who received at least one prior systemic therapy?
The primary objectives of this study are 1.) to conduct a systematic literature review to qualitatively assess from randomized controlled trials (RCTs) the frequencies of specific AEs occurring in adult patients with a diagnosis of advanced/metastatic STS who received prior systemic therapy and 2.) to assess the feasibility of conducting a meta-analysis of placebo-controlled trials identified in Primary Objective 1.
If the results of the systematic literature review warrant sufficient data to conduct a meta-analysis, the secondary objectives of this study are 1.) to select the most appropriate statistical method for a meta-analysis and 2.) to compare the adverse event frequencies associated with pazopanib to the adverse event frequencies associated with each of the other treatments.
For this study, the data sources will include literature cataloged in the following electronic databases: PubMed, Embase (using the Elsevier platform) and Cochrane Central Register of Controlled Trials (CENTRAL)
The design of this study is a systematic literature review, and if feasible, a meta-analysis.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Feasiblity of meta-analysis

Timeframe: n/a

Frequency of adverse events from published clinical trial results

Timeframe: based on length of original study

Secondary outcomes:

Select the approriate method for meta-analysis

Timeframe: n/a

Meta-analysis

Timeframe: n/a

Interventions:
Drug: Axitinib
Drug: Dacarbazine
Drug: Doxorubicin (including liposomal or pegylated)
Drug: Sunitinib
Drug: Trabectedin
Drug: Topotecan
Drug: Sirolimus
Drug: Docetaxel
Drug: Gemcitabine
Drug: Epirubicin
Drug: Vinorelbine
Drug: Crizotinib
Drug: Ifosfamide
Drug: Temozolomide
Drug: Bevacizumab
Drug: Irinotecan
Drug: Vincristine
Drug: Paclitaxel
Drug: Imatinib
Drug: Sorafenib
Drug: Pazopanib
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
2014-13-05
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Sarcoma, Soft tissue
Product
pazopanib
Collaborators
Not applicable
Study date(s)
March 2014 to May 2014
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
  • Study Type: Randomized, controlled (placebo or active comparator) trials, single-blind, double-blind, or triple-blind reporting any of the following adverse events
  • Hematologic
  • Study type
  • Open-label randomized, controlled trials
Inclusion and exclusion criteria
Inclusion criteria:
  • Study Type: Randomized, controlled (placebo or active comparator) trials, single-blind, double-blind, or triple-blind reporting any of the following adverse events
  • Hematologic
  • Anemia
  • Febrile neutropenia
  • Leukopenia
  • Lymphopenia
  • Neutropenia
  • Thrombocytopenia
  • Liver related
  • Aspartate aminotransferase (AST) elevation
  • Alanine aminotransferase (ALT) elevation
  • Bilirubin elevation
  • Gastrointestinal and/or eating related
  • Anorexia/decreased appetite
  • Constipation
  • Decreased weight or weight loss
  • Diarrhea
  • Nausea and/or vomiting
  • Mouth or taste
  • Dysgeusia
  • Mucositis
  • Other
  • Alopecia/hair loss
  • Asthenia
  • Cough
  • Dyspnea/shortness of breath
  • Embolism (including pulmonary and cerebrovascular)
  • Fatigue (tiredness/lack of energy)
  • Fluid retention (bloating; arm or leg swelling; edema)
  • Headache
  • Heart failure
  • Hypertension
  • Infections(s)
  • Myocardial infarction or congestive heart failure
  • Neuropathy/tingling in extremities
  • Pain (any type, including abdominal, musculoskeletal, myalgia, arthralgia)
  • Trouble sleeping/insomnia
  • Subject Type: Adults (aged 18 years or older) with a diagnosis of advanced/metastatic STS received at least one line of systemic therapy before enrollment in a randomized controlled trial of pazopanib or other chemotherapy
Exclusion criteria:
  • Study type
  • Open-label randomized, controlled trials
  • Single-arm clinical trials
  • Preclinical studies
  • Phase 1 studies
  • Prognostic studies
  • Retrospective studies
  • Observational studies
  • Case reports
  • Cohort studies
  • Pediatric studies
  • Commentaries and letters (publication type)
  • Consensus reports
  • Nonrandomized clinical trials
  • Reviews (systematic or nonsystematic)
  • Meta-analyses
  • Population
  • Children (aged < 18 years), or children and adults without presenting separate safety outcomes for adults
  • Adults with STS that is not advanced or metastatic
  • Adults with the following types of STS (in all patients in the study) :
  • Gastrointestinal stromal tumor (GIST)
  • Extra-osseus osteogenic sarcomas
  • Osteosarcoma
  • Ewing tumors
  • Embryonal rhabdomyosarcoma
  • Primitive neuro ectodermal tumor
  • Dermatofibrosarcoma protuberans
  • Malignant mesothelioma
  • Mixed mesodermal tumors of the uterus
  • Interventions including surgery with or without adjuvant chemotherapy, adjuvant chemotherapy, presurgical chemotherapy, radiation therapy, chemotherapy agents other than those listed in the inclusion criteria or any other non-chemotherapy systemic or local treatment
  • Studies reporting adverse events other than the adverse events of interest listed above
  • Studies not reporting any adverse event frequencies

Trial location(s)

No location data available.

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
2014-13-05
Actual study completion date
2014-13-05

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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