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RECRUITING
NCT07400809

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

Sponsor: Tata Memorial Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

350

Start Date

2023-08-23

Completion Date

2027-06-14

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

OTHER

Not applicable- observational study

Not applicable- observational study

Locations (1)

Tata Memorial Hospital

Mumbai, Maharashtra, India