Not yet recruiting NCT06150222
Retrospective Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Concurrent Chemoradiation, Systemic Chemotherapy other locally directed therapies (like surgery, ablation, etc.).
- Who it may be relevant to
- Registry conditions: Cancer, Cervical, Recurrence, Metastasis. Basic parameters: 18 years — 100 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Retrospective Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study (Retro-COSMOS). An EMBRACE Collaborative Initiative in Recurrent and Metastatic Cervix Cancer.
Overview
This multi centric international retrospective study aims to register patients with oligo metastatic and oligo recurrent cervical cancer. The study will register patients in planned period with an aim to analyse clinical outcomes with or without use of radiation in this setting.
Detailed description
Detailed clinical protocol can be obtained by contacting the principal investigator.
Interventions
- Other Concurrent Chemoradiation, Systemic Chemotherapy other locally directed therapies (like surgery, ablation, etc.)
The aim is to include all patients with (induced) oligo metastatic and oligo recurrent settings, irrespective of whether treated with concurrent chemoradiation, systemic chemotherapy, or with other locally directed therapies (like surgery, ablation, etc.)
Primary outcome measures
- 3-year overall survival [Time frame: From date of diagnosis of recurrence untill the date of death due to any cause or date of censoring at the last time the subject was known to be alive, whichever came first, assessed upto 3 years after initiation of the study]
Secondary outcome measures (8)
- 3-year Infield progression free survival [Time frame: From date of first disease progression to date of subsequent progression or death from any cause, whichever came first, assessed upto 3 years after initiation of the study]
- 3- year Progression free survival [Time frame: From date of first disease progression to subsequent disease progression or death from any cause, whichever came first, assessed upto 3 years after initiation of the study]
- Dose response relationship of nodal and visceral progressions [Time frame: From date of start of treatment of disease progression, assessed upto 3 years]
- Dose response relationship within setting of re-irradiation (infield progressions) [Time frame: From date of start of treatment of disease progression, assessed upto 3 years]
- Moderate to severe adverse events within the (induced) oligo-metastatic and oligo-recurrent setting ( including toxicity with targeted agents like bevacuzimab and pembrolizumab) [Time frame: From date of start of treatment of recurrence to end of study, assessed upto 3 years after initiation of the study]
- Report on various risk groups within oligo-metastatic and oligo-recurrent setting [Time frame: From date of recurrence to end of study, assessed upto 3 years after initiation of the study]
- Nomogram which correlates risk groups with expected outcomes within the (induced) oligo-metastatic and oligo-recurrent setting [Time frame: From date of recurrence to end of study, assessed upto 3 years after initiation of the study]
- Tissue based biomarkers [Time frame: From date of start of recurrence to end of study, assessed upto 3 years after initiation of the study]
Eligibility criteria
Inclusion criteria
- Cervical cancer with (induced) oligo-metastatic and/or oligo-recurrent cervix cancer whether treated or not treated with radiation. These patients may have received previous treatment within or outside approved clinical trials/studies.
- Patients with poly-metastatic disease with good response to systemic chemotherapy and treated with radiation to recurrence or metastatic site.
- Patients treated with radical doses at the time of first diagnosis of oligo-metastasis/oligo-recurrence and present with further oligo-progression.
- Patients with oligo-metastasis or oligo-recurrence treated with other locally directed therapies (like surgery, ablation, etc.) are also permitted.
Exclusion criteria
- Gynecological cancer other than cervical cancer
- Persistent Poly-metastatic disease post systemic treatment
- Receiving investigational new drugs at the time of relapse as part of other ongoing trials
- No clinical follow up after treatment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06150222 · MEC-2022-0355/ TMC-IEC-900891