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

NCT06150222 | Not Yet Recruiting DMC

• 1 other identifier: MEC-2022-0355/ TMC-IEC-900891
• Study Type: observational
• Target: 350
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer, Cervical; Recurrence; Metastasis

Keywords

Reirradiation; OligoRecurrence; Oligometastasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

• Dose response relationship of nodal and visceral progressions

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

• Dose response relationship within setting of re-irradiation (infield progressions)

  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)

  From date of start of treatment of recurrence to end of study, assessed upto 3 years after initiation of the study

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 Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with (induced) oligo metastatic and oligo recurrent settings irrespective of whether radiation was used or not.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Tata Memorial Centre: collaborator

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Recurrence; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Supriya Chopra, MD, DNB

  Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

• Remi A Nout, MD, Phd

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rene Vernhout, MSc

CONTACT

+31 107041341; r.vernhout@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Radiation Oncology

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: November 29, 2023
• Study Start: November 30, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 1, 2023

Record last verified: 2023-11