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

NCT ID: NCT06150222

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-30

Study Completion Date

2027-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer, Cervical Recurrence Metastasis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Reirradiation OligoRecurrence Oligometastasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tata Memorial Centre

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Dr. Remi A. Nout

Head of Department of Radiation Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Supriya Chopra, MD, DNB

Role: PRINCIPAL_INVESTIGATOR

Tata Memorial Centre

Remi A Nout, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rene Vernhout, MSc

Role: CONTACT

Phone: +31 107041341

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MEC-2022-0355/ TMC-IEC-900891

Identifier Type: -

Identifier Source: org_study_id