Last updated: 11/10/2021 20:40:06
A retrospective study on treatment patterns and outcomes among recurrent or metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Real-World Evidence-based Treatment Patterns and Outcomes among Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)
Trial description: Given the recent therapeutic advancements for subjects with recurrent or metastatic (R/M) HNCC, there is a need to better understand the impact of anti-Programmed Cell Death Protein (PD1) treatments in the community oncology setting. The aim of this retrospective observational study is to examine subject characteristics, treatment patterns, adverse events and outcomes for subjects with HNSCC who received care in the United states Oncology Network (USON) and initiated treatment between 01-Jan-2016 to 30-Sep-2019. Subjects will be followed longitudinally until last subject record or end of the study period (31-Dec-2019).
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects initiating first line of therapy
Timeframe: Up to 4 years
Number of subjects initiating second line of therapy
Timeframe: Up to 4 years
Number of subjects initiating third line of therapy
Timeframe: Up to 4 years
Time-to-treatment failure
Timeframe: Up to 4 years
Secondary outcomes:
Number of subjects with Baseline demographic characteristics
Timeframe: Up to 4 years
Number of subjects with Baseline clinical characteristics
Timeframe: Up to 4 years
Real world overall survival
Timeframe: Up to 4 years
Time to Next Treatment (TTNT)
Timeframe: Up to 4 years
Response Rate
Timeframe: Up to 4 years
Real world provider-documented progression-free survival (PFS)
Timeframe: Up to 4 years
Number of subjects with adverse events
Timeframe: Up to 4 years
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2021-13-05
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Neoplasms, Head and Neck
Product
GSK3359609
Collaborators
Not applicable
Study date(s)
March 2020 to May 2021
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Not applicable
- Subjects must have a diagnosis of HNSCC.
- Subjects must have >= 2 visits within the USON.
- Subjects cannot be enrolled in clinical trials at any time during the study period.
- Subjects diagnosed with currently active non-HNSCC forms of primary cancer.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects must have a diagnosis of HNSCC.
- Subjects must have >= 2 visits within the USON.
- Subjects must be >=18 years of age at first diagnosis of HNSCC.
Exclusion criteria:
- Subjects cannot be enrolled in clinical trials at any time during the study period.
- Subjects diagnosed with currently active non-HNSCC forms of primary cancer.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2021-13-05
Actual study completion date
2021-13-05
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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