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

N/ANot Yet RecruitingNCT06150222

Erasmus Medical Center350 enrolled

Overview

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 clinical protocol can be obtained by contacting the principal investigator.

Study Type

OBSERVATIONAL

Enrollment

350

Conditions

Cancer, Cervical Recurrence Metastasis

Interventions

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.)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

3-year overall survival

To estimate overall survival of patients diagnosed with oligo-recurrent and (induced) oligo-metastatic cervix cancer.

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

Secondary Outcomes

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.

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

To estimate overall progression-free survival of patients diagnosed with oligo-recurrent and (induced) oligo-metastatic cervix cancer.

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

Radiation Dose-Response Curve will be generated for mean time to nodal and visceral progressions at different dose level

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)

Radiation Dose-Response Curve will be generated for mean time to infield progression at different dose level

Time frame: From date of start of treatment of disease progression, assessed upto 3 years

Central Contacts

Rene Vernhout, MSc

CONTACT

+31 107041341 r.vernhout@erasmusmc.nl

Data from ClinicalTrials.gov

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