RecruitingNCT07400809

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

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


Sponsor

Tata Memorial Hospital

Enrollment

350 participants

Start Date

Aug 23, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Systemic chemotherapy with or without palliative radiation represents the current standard of care in patients with recurrent or metastatic cervix cancer. In addition, pelvic radiotherapy including brachytherapy is also recommended. There is no consensus on the treatment of metastatic site in patients with oligo-metastatic or oligo-recurrent cervix cancer. Also, it is not clear if addition of local treatment to systemic chemotherapy benefits all patients with metastatic disease or a select few with limited systemic disease burden. It's presently unclear which patients derive maximum benefit with integration of radiation at both primary and metastatic site, who develop infield recurrence if performing salvage surgery, locally directed treatments or re-irradiation in addition to systemic chemotherapy improves overall outcomes. The heterogeneity in clinical practice provides an important opportunity to develop a framework for data collection and future studies within such subgroup of patients. In this retrospective study, we aim to determine overall survival, Infield progression free survival, overall progression free survival, dose response relationship of nodal and visceral progressions, and within setting of re-irradiation (infield progressions), severe adverse events and toxicity, risk groups identification, a nomogram which correlates risk groups with expected outcomes, and framework for tissue collection for translational research Investigators will record the parameters in a predesigned proforma without including personal identifiers.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is gathering data from multiple hospitals to better understand how women with cervical cancer that has spread to a limited number of sites (called "oligo-metastatic" or "oligo-recurrent" disease) are treated and how they respond. **You may be eligible if...** - You have been diagnosed with cervical cancer that has spread to a small number of sites (oligometastatic or oligo-recurrent) - You had a strong response to chemotherapy and then received radiation to the cancer sites - You were first diagnosed with only a few metastases and received high-dose radiation, then developed further limited spread - You had other local treatments (surgery, ablation) for limited metastases **You may NOT be eligible if...** - Your gynecologic cancer is a type other than cervical cancer - You have widely spread (polymetastatic) disease that has not responded to chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNot applicable- observational study

Not applicable- observational study


Locations(1)

Tata Memorial Hospital

Mumbai, Maharashtra, India

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NCT07400809


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