Retrospective Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study (Retro-COSMOS)

November 28, 2023 updated by: Prof. Dr. Remi A. Nout, Erasmus Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Detailed clinical protocol can be obtained by contacting the principal investigator.

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Outcome Measure
Measure Description
Time Frame
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
To estimate infield progression-free survival and progression-free interval of patients diagnosed with oligo-recurrent and (induced) oligo-metastatic cervix cancer.
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
To estimate overall progression-free survival of patients diagnosed with oligo-recurrent and (induced) oligo-metastatic cervix cancer.
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
Radiation Dose-Response Curve will be generated for mean time to nodal and visceral progressions at different dose level
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
Radiation Dose-Response Curve will be generated for mean time to infield progression at different dose level
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
Number or percent of participants with treatment-related moderate to severe adverse events as assessed by CTCAE v4.0 (If available)
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
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
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
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.
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
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.
From date of start of recurrence to end of study, assessed upto 3 years after initiation of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Collaborators

Tata Memorial Centre

Investigators

  • Principal Investigator: Supriya Chopra, MD, DNB, Tata Memorial Centre
  • Principal Investigator: Remi A Nout, MD, Phd, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2023

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

September 29, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC-2022-0355/ TMC-IEC-900891

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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