Cervical Cancer
Conditions
Brief summary
Overall survival defined as the time from the date of randomization to the date of death from any cause
Detailed description
Tumour response at the end of standard treatment (concurrent chemoradiotherapy), based on investigator assessments according to both RECIST 1.1 and PERCIST 1.0 criteria, Progression-free survival, defined as the time from the date of randomization to the date of progression (based on investigator assessments according to RECIST 1.1 criteria) or the date of death from any cause, whichever occurs first, Site of disease recurrence (local, pelvic and/or para-aortic lymph nodes, distant), Health-related quality of life, assessed using the EORTC QLQ-C30 questionnaire and the QLQ-CX24 module, Adverse events occurring from the first study treatment administration, assessed based on the NCI-CTCAE version 5.0
Interventions
Sponsors
Centre Hospitalier Universitaire De Toulouse
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival defined as the time from the date of randomization to the date of death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumour response at the end of standard treatment (concurrent chemoradiotherapy), based on investigator assessments according to both RECIST 1.1 and PERCIST 1.0 criteria, Progression-free survival, defined as the time from the date of randomization to the date of progression (based on investigator assessments according to RECIST 1.1 criteria) or the date of death from any cause, whichever occurs first, Site of disease recurrence (local, pelvic and/or para-aortic lymph nodes, distant), Health-related quality of life, assessed using the EORTC QLQ-C30 questionnaire and the QLQ-CX24 module, Adverse events occurring from the first study treatment administration, assessed based on the NCI-CTCAE version 5.0 | — |
Countries
France
Outcome results
None listed