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NCT Number: NCT06150222

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

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.

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Key information

Conditions

Cancer, Cervical Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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)

  6. 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

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rene Vernhout, MSc

CONTACT

[email protected]

+31 107041341

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Tata Memorial Centre

Registry information

Official study title

Retrospective Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study (Retro-COSMOS). An EMBRACE Collaborative Initiative in Recurrent and Metastatic Cervix Cancer.

Acronym: Retro-COSMOS

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 29, 2023
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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