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

Recurrence Clinical Trial

— Retro-COSMOS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06150222
• Other study ID #: MEC-2022-0355/ TMC-IEC-900891
• Status: Not yet recruiting
• Start date: November 30, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: November 2023
• Source: Erasmus Medical Center
• Contact: Rene Vernhout, MSc
• Phone: +31 107041341
• Email: r.vernhout[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastasis
• Neoplasm Metastasis
• Recurrence

Intervention

Other:
• 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.)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Tata Memorial Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year overall survival	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	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.	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
Secondary	3- year Progression free survival	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
Secondary	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	From date of start of treatment of disease progression, assessed upto 3 years
Secondary	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	From date of start of treatment of disease progression, assessed upto 3 years
Secondary	Moderate to severe adverse events within the (induced) oligo-metastatic and oligo-recurrent setting ( including toxicity with targeted agents like bevacuzimab and pembrolizumab)	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
Secondary	Report on various risk groups within oligo-metastatic and oligo-recurrent setting	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
Secondary	Nomogram which correlates risk groups with expected outcomes within the (induced) oligo-metastatic and oligo-recurrent setting	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
Secondary	Tissue based biomarkers	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