Last updated: 03/13/2025 08:50:39
A study of outcomes in advanced endometrial cancer (EC)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A retrospective cohort study of outcomes in advanced endometrial cancer
Trial description: This study will evaluate the effectiveness of current treatment paradigms in the first-line setting for endometrial cancer within the Canadian healthcare landscape.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with advanced and recurrent endometrial cancer (overall and by receipt first-line [1L] of therapy)
Timeframe: Up to 11 years
Number of participants with demographic and clinical characteristics
Timeframe: Up to 11 years
Number of recurrent participants with treatment history
Timeframe: Up to 11 years
Summary of treatment patterns of participants with advanced and recurrent EC
Timeframe: Up to 11 years
Number of participants receiving different forms of systemic treatments (chemotherapy, hormone therapy)
Timeframe: Up to 11 years
Duration of therapy
Timeframe: Up to 11 years
Number of participants with transition from 1L to second line therapy (2L) and from 2L to third line therapy (3L)
Timeframe: Up to 11 years
Overall survival
Timeframe: Up to 11 years
Time to next treatment
Timeframe: Up to 11 years
Time to treatment discontinuation
Timeframe: Up to 11 years
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-01-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Neoplasms, Endometrial
Product
carboplatin
Collaborators
Oncology Outcomes (O2)
Study date(s)
August 2022 to April 2023
Type
Observational
Phase
3
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
Not applicable
- Females 18 plus (+) years with a diagnosis of Type I (low or unknown grade and endometrioid carcinoma) and Type II (High grade or serous/clear/mixed histology) EC will be included.
- Had an advanced/recurrent EC during 01 January 2010 to 31 December 2020. Advanced EC is defined as participants with a confirmed diagnosis of de novo stage III/IV EC. Recurrent EC is defined as participants who presented with early stage (I or II) EC if they had 2+ cycles of chemotherapy, radiation, or death due to EC that occurred more than a year after their first treatment date (surgery, radiation, or systemic therapy). Additionally, for early-stage type I EC, a participant will also be classified as recurrent if they received hormone therapy more than two years after the date of their first treatment, which would be indicative of a hormone-related treatment for disease progression. Participants with missing tumor type characteristics will be classified as Type II if they had evidence of grade 3 or 4 disease or Type I if they had grade 1 or 2 disease or were missing grade data.
- Participants with a uterine sarcoma or other rare subtypes will be excluded.
- Participants with stage I or II EC will be excluded if there was no evidence of a recurrence based on the administrative claims data.
Inclusion and exclusion criteria
Inclusion criteria:
- Females 18 plus (+) years with a diagnosis of Type I (low or unknown grade and endometrioid carcinoma) and Type II (High grade or serous/clear/mixed histology) EC will be included.
- Had an advanced/recurrent EC during 01 January 2010 to 31 December 2020. Advanced EC is defined as participants with a confirmed diagnosis of de novo stage III/IV EC. Recurrent EC is defined as participants who presented with early stage (I or II) EC if they had 2+ cycles of chemotherapy, radiation, or death due to EC that occurred more than a year after their first treatment date (surgery, radiation, or systemic therapy). Additionally, for early-stage type I EC, a participant will also be classified as recurrent if they received hormone therapy more than two years after the date of their first treatment, which would be indicative of a hormone-related treatment for disease progression. Participants with missing tumor type characteristics will be classified as Type II if they had evidence of grade 3 or 4 disease or Type I if they had grade 1 or 2 disease or were missing grade data.
Exclusion criteria:
- Participants with a uterine sarcoma or other rare subtypes will be excluded.
- Participants with stage I or II EC will be excluded if there was no evidence of a recurrence based on the administrative claims data.
- Participant has a concomitant malignancy or has a prior non-endometrial invasive malignancy who has been disease-free for less than (<)3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed
- Participants who received prior therapy with anti-programmed cell death protein 1 (PD-1), anti- programmed death-ligand 1 (PD-L1) or anti-programmed death/death ligand (anti-PD-LD) agent for any cancer.
- Participant with uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
- Participant participating in a clinical trial. This will be identified in the administrative databases (Alberta Cancer Registry [ACR], ARIA). These databases include a flag/field that denotes whether person has been on a trial ever or has received a trial drug.
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
2023-01-04
Actual study completion date
2023-01-04
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
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