Cancer, CervicalRetro-COSMOSNCT06150222
Retrospective Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study
An observational study of Cancer, Cervical and Recurrence, run by Erasmus Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Cancer, Cervical, Recurrence, Metastasis
- What is being tested?
- Concurrent Chemoradiation, Systemic Chemotherapy other locally directed therapies (like surgery, ablation, etc.)
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2023to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients with (induced) oligo metastatic and oligo recurrent settings irrespective of whether radiation was used or not.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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.
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.
Read the detailed description
Detailed clinical protocol can be obtained by contacting the principal investigator.
- Conditions
- Cancer, Cervical, Recurrence, Metastasis
- Being tested
- Concurrent Chemoradiation, Systemic Chemotherapy other locally directed therapies (like surgery, ablation, etc.)
- Keywords
- Reirradiation, OligoRecurrence, Oligometastasis
- Medical subject headings
- Uterine Cervical Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent Chemoradiation, Systemic Chemotherapy other locally directed therapies (like surgery, ablation, etc.)Other
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.)
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival
To estimate overall survival of patients diagnosed with oligo-recurrent and (induced) oligo-metastatic cervix cancer.
Measured: 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 (8)
3-year Infield progression free survival
To estimate infield progression-free survival and progression-free interval of patients diagnosed with oligo-recurrent and (induced) oligo-metastatic cervix cancer.
Measured: 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
To estimate overall progression-free survival of patients diagnosed with oligo-recurrent and (induced) oligo-metastatic cervix cancer.
Measured: 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
Radiation Dose-Response Curve will be generated for mean time to nodal and visceral progressions at different dose level
Measured: From date of start of treatment of disease progression, assessed upto 3 years
Dose response relationship within setting of re-irradiation (infield progressions)
Radiation Dose-Response Curve will be generated for mean time to infield progression at different dose level
Measured: 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)
Number or percent of participants with treatment-related moderate to severe adverse events as assessed by CTCAE v4.0 (If available)
Measured: 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
Clinical, pathological, and treatment-related factors of patients recorded during the sudy will be used to develop multivariable risk models to identify risk factors and define various risk groups within oligo-metastatic and oligo-recurrent setting
Measured: 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
Nomogram will be developed which could estimate the probability of a expected outcomes (overall survival, infield progression free survival, overall progression free survival) based on the risk group the patient belongs to within oligo-metastatic and oligo-recurrent setting.
Measured: From date of recurrence to end of study, assessed upto 3 years after initiation of the study
Tissue based biomarkers
Sponsor Institute will facilitate storage of biopsy tissue of patients within oligo-metastatic and oligo-recurrent setting included in this study. In future, these tissue samples will be used for translational reseach in this field.
Measured: From date of start of recurrence to end of study, assessed upto 3 years after initiation of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start30 Nov 2023 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, CervicalStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tata Memorial Centre
- Responsible party
- Principal investigator, Prof. Dr. Remi A. Nout, Erasmus Medical Center
- Investigators
- Supriya Chopra, MD, DNB, Principal investigator, Tata Memorial CentreRemi A Nout, MD, Phd, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150222
- Sponsor's protocol ID
- MEC-2022-0355/ TMC-IEC-900891
- Acronym
- Retro-COSMOS
- Status last verified
- Nov 2023
- First submitted
- 29 Sep 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study (Retro-COSMOS). An EMBRACE Collaborative Initiative in Recurrent and Metastatic Cervix Cancer.
- ClinicalTrials.gov ID
- NCT06150222
- Acronym / sponsor ID
- Retro-COSMOS / MEC-2022-0355/ TMC-IEC-900891
- Conditions
- Cancer, Cervical, Recurrence, Metastasis
- Keywords
- Reirradiation, OligoRecurrence, Oligometastasis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Tata Memorial Centre
- Study start
- 30 Nov 2023 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with (induced) oligo metastatic and oligo recurrent settings irrespective of whether radiation was used or not.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.) | Other | – |
Primary outcome
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
To estimate overall survival of patients diagnosed with oligo-recurrent and (induced) oligo-metastatic cervix cancer.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Supriya Chopra, MD, DNB principal investigator
Tata Memorial Centre
Remi A Nout, MD, Phd principal investigator
Erasmus Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, Cervical and Recurrence, run by Erasmus Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rene Vernhout, MSc (+31 107041341, r.vernhout@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.