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

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Другое 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.)

Первичные конечные точки

• 3-year overall survival [Срок оценки: 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]

Вторичные конечные точки (8)

• 3-year Infield progression free survival [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From date of start of treatment of disease progression, assessed upto 3 years]
• Dose response relationship within setting of re-irradiation (infield progressions) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From date of recurrence to end of study, assessed upto 3 years after initiation of the study]
• Tissue based biomarkers [Срок оценки: From date of start of recurrence to end of study, assessed upto 3 years after initiation of the study]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06150222 · MEC-2022-0355/ TMC-IEC-900891

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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