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

Not yet recruiting

• Conditions: Recurrence; Metastasis; Cancer, Cervical

• Registration Number: NCT06150222
• Lead Sponsor: Erasmus Medical Center

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2023-09-29
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-20
• Last Update Submitted: 2023-11-28
• Study First Posted: 2023-11-29
• Study Start: 2023-11-30
• Last Update Posted: 2023-12-01
• Primary Completion: 2026-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 350

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-year overall survival	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 Outcome Measures

Name	Time	Method
Moderate to severe adverse events within the (induced) oligo-metastatic and oligo-recurrent setting ( including toxicity with targeted agents like bevacuzimab and pembrolizumab)	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)
Report on 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	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
3- year Progression free survival	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.
Dose response relationship of nodal and visceral progressions	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
Nomogram which correlates risk groups with expected outcomes within the (induced) oligo-metastatic and oligo-recurrent setting	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.
3-year Infield progression free survival	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.
Dose response relationship within setting of re-irradiation (infield progressions)	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
Tissue based biomarkers	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.