Clinical trial NCT06150222: Retrospective Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study
Official title: Retrospective Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study (Retro-COSMOS). An EMBRACE Collaborative Initiative in Recurrent and Metastatic Cervix Cancer.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer, Cervical
Recurrence
Metastasis
Keywords: Reirradiation
OligoRecurrence
Oligometastasis
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Tata Memorial Centre
First posted: 2023-11-29
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with (induced) oligo metastatic and oligo recurrent settings irrespective of whether radiation was used or not.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patients with poly-metastatic disease with good response to systemic chemotherapy and treated with radiation to recurrence or metastatic site.
3. Patients treated with radical doses at the time of first diagnosis of oligo-metastasis/oligo-recurrence and present with further oligo-progression.
4. Patients with oligo-metastasis or oligo-recurrence treated with other locally directed therapies (like surgery, ablation, etc.) are also permitted.

Exclusion Criteria:

1. Gynecological cancer other than cervical cancer
2. Persistent Poly-metastatic disease post systemic treatment
3. Receiving investigational new drugs at the time of relapse as part of other ongoing trials
4. No clinical follow up after treatment

Primary outcomes:
measure: 3-year overall survival
timeFrame: 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 outcomes:
measure: 3-year Infield progression free survival
timeFrame: 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
measure: 3- year Progression free survival
timeFrame: 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
measure: Dose response relationship of nodal and visceral progressions
timeFrame: From date of start of treatment of disease progression, assessed upto 3 years
measure: Dose response relationship within setting of re-irradiation (infield progressions)
timeFrame: From date of start of treatment of disease progression, assessed upto 3 years
measure: Moderate to severe adverse events within the (induced) oligo-metastatic and oligo-recurrent setting ( including toxicity with targeted agents like bevacuzimab and pembrolizumab)
timeFrame: From date of start of treatment of recurrence to end of study, assessed upto 3 years after initiation of the study
measure: Report on various risk groups within oligo-metastatic and oligo-recurrent setting
timeFrame: From date of recurrence to end of study, assessed upto 3 years after initiation of the study
measure: Nomogram which correlates risk groups with expected outcomes within the (induced) oligo-metastatic and oligo-recurrent setting
timeFrame: From date of recurrence to end of study, assessed upto 3 years after initiation of the study
measure: Tissue based biomarkers
timeFrame: From date of start of recurrence to end of study, assessed upto 3 years after initiation of the study
Other outcomes:
Locations:
Study officials:
affiliation: Tata Memorial Centre
name: Supriya Chopra, MD, DNB
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Remi A Nout, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: